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Design Controls - Requirements for Medical Device Developers
 
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The FDA expects companies to perform meaningful, results driven Design Control activities as defined in the CFR, for both new and changed devices. The company is held fully responsible for deciding when to start and the specific documentation to meet the 9 requirements. Beyond compliance, these 9 elements can be a powerful tool in reducing "time to market" – "fast cycle" product development. For More Information Contact - Organization: NetZealous BDA GlobalCompliancePanel Website: http://www.globalcompliancepanel.com/ Email: [email protected] Help us caption & translate this video! http://amara.org/v/LJLB/
Medical Device Product Development: the process is more than design controls
 
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Product development is a complex process, which requires integration of business and technology to deliver a successful product. Medical devices must also follow the requirements of design controls, which are based on engineering best practices for product development. We often see companies using the required elements of design controls as their product development process, at the risk of ignoring the business elements needed for a successful product. Learn more...
Views: 1071 Strategy2Market
Harvard i-lab | Understanding Medical Device Development
 
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The healthcare industry is a hot bed of innovation. A convergence of new technologies, connectivity, big data and analytic models are creating a multitude of opportunities to improve health outcomes and reinvent platforms for device and service businesses. Working in a regulated industry requires special considerations that can prove challenging for the uninitiated. From concept generation to launch, this session, led by Aidan Petrie, Chief Innovation Officer of Ximedica, will provide an overview of six essential components of successful product development specific to the development of medical devices and healthcare products. We will start with a discussion around the regulatory considerations that drive many of the activities surrounding each of the development phases and then cover step-by-step each phase of development including an overview of funding milestones and potential sources. Part how-to, part know-how the aim of this short workshop is to equip anyone who is currently trying to bring a product to market or may do in the future with a high level view from experts in the field. Ximedica is the largest product developer the country that is focused solely on the medical space. Our clients range from Fortune 30, VC's, university incubators and everything in between.
Design Control
 
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Leverage and enforce best practices for product development teams, and follow a common design control and product realization process. Learn more about PTC's commitment to healthcare at : http://ptc.co/auKW30hRoYV
Views: 222 PTC
Implementing Design control for Medical Devices and IVDs
 
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Device manufacturers are required to establish and maintain the FDA-compliant quality management systems, where appropriate and applicable, including design control. This webinar is intended to provide guidance on understanding, interpreting, and implementing design control requirements.
Lean and Agile in Medical Device Product Development
 
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Some medical device companies feel that lean and agile techniques cannot be used because of design controls. However, the regulations don’t prevent the use of those techniques during product development. This webinar discusses these issues in more detail.
Views: 411 Strategy2Market
The first secret of great design | Tony Fadell
 
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As human beings, we get used to "the way things are" really fast. But for designers, the way things are is an opportunity ... Could things be better? How? In this funny, breezy talk, the man behind the iPod and the Nest thermostat shares some of his tips for noticing — and driving — change. TEDTalks is a daily video podcast of the best talks and performances from the TED Conference, where the world's leading thinkers and doers give the talk of their lives in 18 minutes (or less). Look for talks on Technology, Entertainment and Design -- plus science, business, global issues, the arts and much more. Find closed captions and translated subtitles in many languages at http://www.ted.com/talks/tony_fadell_the_first_secret_of_design_is_noticing Follow TED news on Twitter: http://www.twitter.com/tednews Like TED on Facebook: https://www.facebook.com/TED Subscribe to our channel: http://www.youtube.com/user/TEDtalksDirector
Views: 850149 TED
Modeling, Simulation, and Flight Control Design of an Aircraft with Simulink
 
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See what's new in the latest release of MATLAB and Simulink: https://goo.gl/3MdQK1 Download a trial: https://goo.gl/PSa78r In this webinar, you will learn how you can apply Model-Based Design with MATLAB and Simulink for air vehicle design and automatic flight control. Engineers working in the aerospace field can use MATLAB and Simulink to improve the design workflow for: • Defining aircraft geometry and importing DATCOM data to define vehicle forces and moments • Creating a simulation to understand the vehicle dynamics • Designing a flight control system with automatic gain generation to stabilize the vehicle and meet requirements • Performing simulations to verify the design and visualize the simulation in a realistic 3D environment The primary focus is for engineers whose workflow involves modeling, simulation, and control of aircraft. Many of the Model-Based Design and control concepts shown in this webinar can be applied to a variety of applications. About the Presenter: Ryan Gordon is the product manager for Aerospace Toolbox and Aerospace Blockset at MathWorks. Before joining MathWorks, Ryan developed models and control algorithms for autonomous UAVs using Simulink at Northrop Grumman Aerospace Systems. He has a bachelor’s degree in aerospace engineering from Saint Louis University and a master’s degree in aerospace engineering focusing on dynamics and control from USC.
Views: 25796 MATLAB
How product design can change the world | Christiaan Maats | TEDxUniversityofGroningen
 
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Christiaan Maats is a designer and entrepreneur who challenges the way we look at product design. Going beyond form and function he shows us how products carry deeper layers of meaning and how those layers can connect us to a bigger reality. In this Talk, Christiaan Maats explains how meaningful products can embody the change we want to see in the world and sheds light on his own vision of a circular society that integrates industrial society with its natural roots. Christiaan Maats was born and raised in Groningen, though he studied Industrial Design Engineering at Technical University in Delft. His keen interest in the psychology behind product- and brand experience took him to Sydney, Australia where he conducted a case study titled “Storytelling through Product Design”. Good product design is good storytelling, according to Christiaan. His creation of the world’s first biodegradable shoes that bloom is a perfect example of his philosophy. Christiaan considers himself a practical idealist. He is driven by his passion for innovation and creating products and brands that inspire a better future by making you smile, think and wonder. His refreshing ideas on sustainable innovation disrupt the status quo. Christiaan's diverse background and enthusiasm are great ingredients for an inspiring TEDx Talk that focuses on the society of the future and how to get there. This talk was given at a TEDx event using the TED conference format but independently organized by a local community. Learn more at http://ted.com/tedx
Views: 59539 TEDx Talks
How To Sketch Like A Product Designer
 
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How To Sketch Like A Product Designer ***My Website Designlifebrand.com Instagram: #Designlifebrand Youtube:https://www.youtube.com/channel/UCQrWw1x0aHeiSG5EH6mP4Mw/videos Must Have Tools for Industrial Designers! Cheaper Calipers https://amzn.to/2DYmgCs Mitutoyo Calipers https://amzn.to/2I8BNCa ***My Video Gear! Camera: Panasonic G85 https://amzn.to/2pKWXyv Microphone: Blue Yeti https://amzn.to/2pKzGgb Amazing Work: https://www.youtube.com/user/SangwonSeok https://www.behance.net/gallery/32146389/Auto-Helmet https://www.behance.net/gallery/59271515/DURO-Modular-Crutch https://www.behance.net/gallery/58747871/Design-sketches-Fall-2017 https://www.behance.net/gallery/30098817/TOKYO-OLYMPICS-VEHICLE-2020 https://www.behance.net/gallery/57515611/Sketches-2017-(Part-5) https://www.behance.net/gallery/58804895/Luminaire-MAGISTRAL-LED https://www.behance.net/gallery/24118995/Sunday-Sketches https://www.behance.net/gallery/59406491/turnsole-A-lamp-design-prototype https://www.behance.net/gallery/53144851/Aer https://www.behance.net/gallery/59358523/Community-Assistant-Drone https://www.behance.net/gallery/21742541/Sketchbook https://www.behance.net/gallery/56291059/Furniture-Speaker-series-Kartell https://www.behance.net/gallery/56975271/LUX-Car-Air-Purifier-and-On-The-Go-Air-Monitor https://www.behance.net/gallery/59661669/ONE-PIECE https://www.behance.net/gallery/59596851/PORTFOLIO-2017 Behance: https://www.behance.net/jimmyhuynhea5d Instragram: https://www.instagram.com/jimmyhuynhdesign/ Podcast: http://www.halfhourintern.com/careers/industrial-designer-with-jimmy-huynh Facebook: https://www.facebook.com/JimmyHuynhDesign/ -------------------------------------- My Video Gear! -Camera: Panasonic G85 https://amzn.to/2pKWXyv -Microphone: Blue Yeti https://amzn.to/2pKzGgb I make these videos on my spare time to share my knowledge. If you enjoyed my videos and want to donate, listed is my bitcoin address. Thank you. 125ZGMRrGAtvbC7BoTziyu9v1AC9A9yYeu
Views: 206565 Jimmy Huynh
Role of RA Specialist in the Design Process
 
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Course Description: This course focuses specifically on the responsibilities of the Regulatory Affairs (RA) specialist within the medical device manufacturer’s design process. It features a comprehensive illustration of the RA specialist’s role in the following areas: - Design control - Regulatory documentation - Submissions - Product launch - Design changes Learn more at: http://www.wmdo.org/course-detail.aspx?id=68
Views: 1879 WMDO
FDA Expectations for Traceability in Device & Diagnostic Design
 
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This is a recording of Seapine's webinar on FDA Design Traceability Requirements for Device Development with John Avellanet, Managing Director & Principal at Cerulean Associates, LLC, and Larry Nicholson, Business Development Manager for Life Sciences at Seapine Software. Additionally, you download the FDA Expectations for Traceability in Device Design slide deck and view the Q&A on our blog: http://bit.ly/oAQsnD
Views: 3981 seapineview
Medical Device Design and Development | Combination Products | Design Control
 
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Get Medical Device Design and Development Guidance. https://www.operonstrategist.com/medical-device-design-development/ Also know about drug-device combination products, medical device design control, 21 CFR 820.30.
Mitigating and Managing Risk for Medical Device Product Development [Polarion Webinars]
 
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Thank you for watching our webinar teaser. View the full recording here: https://www.polarion.com/webinar-on-demand/Mitigating-and-Managing-Risk-for-Medical-Device-Product-Development?utm_campaign=YT2015&utm_medium=social&utm_source=youtube The development of safety-critical medical devices presents special challenges at every step, from product conceptualization through design, development and testing, to regulatory approval and post-market oversight and support. Polarion's interactive webinar will help regulatory, quality and R&D professionals understand the special issues of product development and how they relate to risk management in a regulated environment, including EN ISO-14971.
Views: 150 PolarionSoftware
Making sense of MVP (Minimum Viable Product)
 
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Adapted from Crisp's blog by Henrik Kniberg. Explaining his MVP drawing. This drawing shows up all over the place, in articles and presentations, even in a book (Jeff Patton’s “User Story Mapping” – an excellent read by the way). Many tell me the drawing really captures the essence of iterative & incremental development, lean startup, MVP (minimum viable product), and what not. However, some misinterpret it, which is quite natural when you take a picture out of it’s original context. Some criticize it for oversimplifying things, which is true. The picture is a metaphor. Find the original article here: http://blog.crisp.se/2016/01/25/henrikkniberg/making-sense-of-mvp Video by The CRM Team. For more great content have a look at our resources page here: http://thecrmteam.com/resources/
Views: 93407 The CRM Team
Managing Requirements in Medical Product Development – Sunrise Labs
 
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Jim Turner, Sunrise Labs' Program Manager/Software Engineering Group Leader, discusses Managing Requirements: A Systems Approach to medical device requirements for efficient and compliant design and development at BIOMEDevice 2015. Sunrise Labs outlines a Systems based framework to Requirements Management, which provides the rigor required for medical product development with the appropriate level of documentation and testing. This framework has been created based on over 20+ years of medical device development experience, and provides a method to tailor your requirements to risk and level of classification. Requirements Management is core to FDA design controls. Defining, planning, implementing, testing and tracing requirements efficiently and effectively have enormous benefits for the initial development, maintenance, and life cycle of a medical device.
Views: 188 Sunrise Labs, Inc.
GX - PRODUCT DESIGN ENGINEERING & CONTROL SYSTEM DEVELOPMENT
 
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If you want to know more about who we are and what we do take a look behind the scenes at GX #productdesigners turning products into #commercialreality
Successful Strategies for Medical Device FDA & CE Approval
 
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http://sterlingmedicaldevices.com How much trouble and effort will it take to get FDA and CE Approval for my medical device? Regulators want to see a very specific design process, strong quality control, robust risk management and an airtight submission package. At Sterling Medical Devices, the FDA has accepted our thorough Design History Files (DHF) every time, showing that we have tried to think of every possible scenario through software verification and medical device testing. We ensure that the medical device software and medical device hardware are doing what they are supposed to be doing and designed to do. Learn more from Bruce Swope, VP of Engineering, who has over 25 years' management experience in medical device development, and John Campbell, Director of Quality, who has over 20 years in medical device development, device testing and verification. Contact Bruce to learn more. Visit: http://sterlingmedicaldevices.com/contact-us Email: [email protected] Call 201-227-7569 x2.
Development of Tools to improve efficiency Industrial and Engineering Design
 
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Kato Laboratory Department of Mechanical Engineering, Faculty of Science and Technology, Keio University "Development of Tools to improve efficiency Industrial and Engineering Design" The Kato Laboratory in the Department of Mechanical Engineering, Faculty of Science and Technology, Keio University is conducting research on design theory and methodology for effective design that is crucial to ptoduct developments, and it also researches product design that applies the theory and methodology. "User demands for products have become diversified in recent years. As a result, not only are products becoming more complex with greater functionality, their design processes have also become more complex. At our lab, we are conducting research on techniques and tools so that product design can be carried out more effectively and efficiently." The Kato Laboratory conducts research on three main topics: optimal design, in which multiple specifications and evaluations concerning design are optimized; design management, in which specifications and processes are managed and design reworkings are minimized; and Kansei (sensitivity) design, in which people's feelings and impressions are valued. "Within optimal design, Our Laboratory is particularly focused on robust optimal design. Optimal design sets design parameters for best performance, while robust optimal design is not only concerned with performance quality, it also aims to reduce performance variation due to product user or usage environment. Although it may appear that the only variable added is variation, in fact when variation is taken into consideration, the amount of calculations needed for optimization greatly increases. Our Laboratory is developing an algorithm for efficient optimization." In addition, research on design management involves the study of techniques to support accurate and smooth operations sought by designers. "Designers do their design work while organizing and and arranging a huge number of the items that must be addressed in the design process. If this does not go well, design reworkings will occur due to the design and specification changes, which leads to increased development costs and time. As such, design management is very important. Our Laboratory is developing an analysis tool for organizing the relationship between the numerous items." The Kato Laboratory uses the techniques of quality function deployment and design structure matrix—which are capable of organizing complex relationships between items such as customer design requests, function, physical characteristics, and parts—to develop tools that can visually display these relationships in an easy to understand manner. The laboratory is also developing products that use these tools. In research on Kansei design, methods to evaluate beauty of two- and three-dimensional shapes are being studied. "As with the golden ratio that is found in many works of art and architecture, shapes considered to be “beautiful” are said to be characterized by some hidden rule. If this rule can be discovered and “beauty” is quantified, it can be used to support styling design of products." "Our Laboratory is focused on curved lines and surfaces and proposed a system for evaluating cognitive features of shapes said to influence beauty, including complexity and order, which uses an index related to curvature variation." In addition, the Kato Laboratory uses Near-infrared Spectroscopy (NIRS) equipment to measure cerebral blood flow changes as it aims to quantitatively evaluate impressions felt by people when they see a design. Focused on these three research areas, by quantifying the design process and people's sensitivities, the Kato Laboratory is aiming to bring about AI-coordinated design and automated design. "Through this research, we want to improve the design activity, and to contribute if even in a small way to the manufacturing industry."
Medical Device PLM   Design Control
 
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Learn why PLM is important for Medical Device companies and how Minerva's Medical Device PLM solution can help. This video focus on Design Control
Views: 721 MinervaPLM
Compliance meets Innovation - PLM for Medical Device Development
 
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Nordic innovation leaders in medical device development master design controls and regulatory complexity while radically cutting lead time in product development. The key to excellence is ENOVIA PLM – embedding quality and regulatory accuracy in your daily product development work - sharing one current product definition across the extended enterprise. This webinar was broadcaster 2014-06-10
Views: 51 TechniaTranscat
System Design Interview Question: DESIGN A PARKING LOT - asked at Google, Facebook
 
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In-depth system discussion of a popular coding interview question, chapters: 0:32 Problem statement 0:55 Finding a solution 2:43 Questions to ask 6:35 Object oriented design/class hierarchy 13:57 Coding question approach 23:34 Testing This system design interview question/how to system design is for software engineers, software developers, web developers, front end engineers, QA engineers, product managers, network engineers equally important. This interview problem can be asked as a coding interview question, system design question or object oriented design question. SiT website: www.successintech.com Facebook: https://www.facebook.com/SuccessInTech/ Twitter: www.twitter.com/successintech Other names for this problem are: Amazon Locker interview question, The Parking Lot interview question, Parking Lot using OO techniques, Object oriented parking lot. Music: www.bensound.com
Views: 203633 Success in Tech
Mastering Design Control with Medical Device PLM
 
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For Medical Device manufacturers, managing design control is often linked with frustration because of its time-consuming processes. With Medical Device PLM you can easily manage your design controls with Design History File and Device Master Record
Views: 158 MinervaPLM
Product Development Process - Product Approvals, Step 3
 
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Electronics | Software Development | Product Development | Electronic Engineering http://www.khemeiaconsulting.com/ Ian Sharp, MD of Khemeia Consulting, talks about the Product Development process. Step 3: Approvals for your product Whichever market you go into, there will be different approvals that apply for your product. Some approvals can be more stringent than others - for example, medical. In this situation, it's not just about designing a "safe product". but you also have to: - implement the right process in that design - control the supply chain - ensure the product is standardised and controlled By doing al this you will ensure your product passes all the safety and performance approvals. Different geographical regions have different approvals. Khemeia Consulting | Technology | Electronics | Electronic Design Services | Software | Product Development
Agile Methods in Medical Device Development - Full Length Meetup
 
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Agile Methods in Medical Device Development Agile methods are well established in software development, and have been recognized by FDA as a valid alternative to the waterfall development approach typically applied in medical device Design Control systems. By drawing on personal experiences using agile methods in medical device development, the speaker will explore: • How agile methods can work for systems (hardware as well as for software) • How to leverage an agile approach most effectively in a regulated environment • How to incorporate external partners – including product development teams – in an agile development framework. Chris Danek, PhD, MBA – Interim Executive and Advisor Chris helps commercial and pre-commercial life sciences companies achieve operational excellence. Chris co-founded AtheroMed (acquired by Volcano) and was its CEO and later CTO. Earlier, he served as VP, R&D at Asthmatx (acquired by Boston Scientific). He has extensive experience leading cross-functional teams in the development of innovative solutions to difficult clinical problems, and as a senior manager of R&D, Operations, and Quality. Chris received a PhD in mechanical engineering from Stanford University, an MBA from The Wharton School, University of Pennsylvania, a Bachelor of Mechanical Engineering from The Catholic University of America, and is an inventor on over 50 US patents. For more information on Focus Product Design visit: http://www.focuspdm.com/services/medical-devices For more Meetups on Product Design at Focus visit our Meetup group here: http://www.meetup.com/Silicon-Valley-Entrepreneurs-Network/
Views: 1141 a
Project Management for Medical Device Development
 
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Project Management Seminar Series Erin McKenna, MBA December 10, 2014
Medical Device PLM   Design Control Demo Traceability Matrix
 
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In this, the third video in the Medical Device PLM series, we show you how you can use Minervas Medical Device PLM solution to get a tracability matrix that will provide full traceability between requirements, documentation, changes, actions, risk, validation and verification.
Views: 684 MinervaPLM
Quality by Design   Essential Techniques for Medic
 
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Quality by Design - Essential Techniques for Medical Devices (NTZ) At DoubleTree by Hilton Hotel San Diego Downtown San Diego, CA For more information: https://www.eventbrite.com/e/quality-by-design-essential-techniques-for-medical-devices-ntz-tickets-45929310805?aff=RMV DESCRIPTION ===================== Quality by Design - Essential Techniques for Medical Devices Design Controls are essential for producing safe and effective medical devices. And Design Controls are considered a critical process by the FDA. Yet, Design Controls are still one of the most frequent areas for 483 and Warning Letter observations. This two-day seminar will help you understand, develop, and implement Design Controls processes and tools that are a competitive strength for your company. You will learn how to incorporate Design Controls into your product development process to help streamline development and ensure Quality and compliance. In this seminar, we will cover Design Controls for medical devices. We will understand the requirements for Design Controls and how to translate them into an efficient and effective process for your company. We'll cover the history, context, and requirements for Design Controls. Then we'll discuss requirements and tools in detail and include exercises to help you practice and improve your Design Control process. Why you should attend: ====================== The intrinsic quality, safety, and effectiveness of medical devices are established during the design phase. Yet, statistics show that a significant percentage of all medical device recalls are due to design problems. And those design problems can have disastrous results for your customer and for your company. A rigorous and efficient Design Control process can help avoid these quality and compliance problems. Issues that are identified early are more easily and quickly resolved. This seminar will help you avoid design problems and their impact on Quality, cost, speed to market, and customer satisfaction. Design Control is one of the critical areas covered by the FDA in inspections of medical device companies. Design issues can also result in complaints from your customers and in medical device reports. Design issues can even create issues with manufacturability for your company including low yields and excessive scrap and rework. Finding and fixing issues early on in design provide much more leverage than trying to fix problems for products already in production. This webinar can help you learn from past issues and improve your next generations of product. Learning Objectives: ====================== Using interactive discussion and exercises, students will understand the regulations, context, and history of Design Controls. They will learn how to use Design Control as a tool to ensure product quality while meeting business needs for speed to market. They will come away with key concepts, practice in these concepts, and extensive course notes for future use and reference: Expectations Regulations and History Design Control process, procedures, forms, records, files Linkages to the rest of your Quality Management System Lessons Learned Myths Challenges Best Practices Inspection Readiness Who Will Benefit: ===================== R&D Engineers R&D Project Leaders R&D Managers and Directors Individuals participating in Product Design and Development Individuals participating in design changes and failure investigations Regulatory Affairs Design Quality Engineers R&D engineers and scientists Compliance Specialists Auditors Senior Management Anyone new to Design Control Please contact the event manager Marilyn below for the following: - Discounts for registering 5 or more participants. - If your company requires a price quotation. Event Manager Contact: marilyn.b.turner(at)nyeventslist.com You can also contact us if you require a visa invitation letter, after ticket purchase. We can also provide a certificate of completion for this event if required. ---------------------------------- For more information: https://www.eventbrite.com/e/quality-by-design-essential-techniques-for-medical-devices-ntz-tickets-45929310805?aff=RMV Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675 Twitter: https://twitter.com/nyeventslist Facebook: https://www.facebook.com/NewYorkEventsList New York Events List: http://nyeventslist.com/
How Are Medical Devices Developed? The Engineering Process at SpineFrontier Inc.
 
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Are you a surgeon interested in working on product development with us? Visit http://www.spinefrontier.com/ to learn more about us and contact us to schedule a VIP Tour at our Greater Boston area facilities.
Views: 582 SpineFrontier
Design Case Study : Medical Product Design PUVA Medical Chamber
 
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An award winning PUVA medical device design process. For more please check our website. http://www.udlab.in https://www.behance.net/bhagvanjisonagra https://www.instagram.com/sonagrabm
Views: 192 UDLAB LLP
Development and Delivery of Pharmaceutical Products  (CMC) - MaRS Best Practices
 
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Moving from drug discovery to drug development requires a particular skillset usually not yet honed by start-ups. This phase of the development process is highly regulated and critical. Let Dr. Colin Minchom take you through the aspects of the Chemistry, Manufacturing and Control (CMC) portion of the drug development process. Watch this video to learn about the pharmaceutical product development which includes objectives of formulation, cost-effective strategies to reach key milestones and more. MaRS -- Building Canada's next generation of global technology companies. marsdd.com
The Future of Design
 
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SpaceX is exploring methods for engineers to accelerate their workflow by designing more directly in 3D. We are integrating breakthroughs in sensor and visualization technologies to view and modify designs more naturally and efficiently than we could using purely 2D tools. We are just beginning, but eventually hope to build the fastest route between the idea of a rocket and the reality of the factory floor. Special thanks to Leap Motion, Siemens and Oculus VR, as well as NVIDIA, Projection Design, Provision, and to everyone enabling and challenging the world to interact with technology in exciting new ways.
Views: 2803967 SpaceX
Medical Device PLM   Design Control Demo   DHF DMR
 
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This is the second video in our Medical Device video series. In this video you will get a demonstration of how Minerva's Medical Device PLM solution solves the complex task of creating, managing, updating and baselining the DHF and DMR
Views: 549 MinervaPLM
Demystifying Medical Device Design Control Requirements: Audio Educator
 
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Click here for more Information: http://www.audioeducator.com/pharma-biotech/medical-device-design-control-requirements-10-15-2014.html Demystifying Medical Device Design Control Requirements, DHF, DHR, and DMR Presented By: Dr. David Lim, Ph.D., RAC, ASQ-CQA Know the Best Practices for Documentation of Medical Necessity, Critical Care and Other Timed Services! More Videos: - http://www.youtube.com/user/audioeducator2 You can also connect with us on Twitter, Facebook, Google+ and LinkedIn and get the most updated news and views, expert advice and tips to help resolve your coding, billing & compliance dilemmas quickly and accurately. Connect with us on Twitter: - https://twitter.com/audioeducator Facebook: - https://www.facebook.com/pages/AudioEducator/244912592201260 LinkedIn: - http://www.linkedin.com/company/audio-educator Google+: - https://plus.google.com/102668946943256059069/posts
Views: 237 AudioEducator
WEBINAR: ISO13485: 2016 – An Overview of General and Product Realisation Requirements
 
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In 15 minutes, ascertain the major changes to the new ISO 13485: - Impacts of the new revision - New terminology - General requirements - Resource management - Product realisation and design controls - Q&A session Led by Richard Young, trainer for MDTI's Managing the Transition to the new IVD Regulation and Practical Guidance for Medical Device Audits and Inspections courses.
The IKEA Group - The Story of How We Work
 
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To create a better everyday life for the many people: that is the IKEA vision. But, what exactly do we mean by this? How can a home furnishing company create a better everyday? http://www.IKEA-usa.com We believe quality and design should be affordable to many. We use the five elements of "democratic design" -- form, function, quality, sustainability and a low price. So instead of thinking outside the box, we got rid of it. At IKEA, we want to inspire people to create the home they dream of. Follow us on a journey from home through design, supply and distribution to find out how they come together to create quality products at low prices. To us, creating a better everyday life for the many people also means making a difference for the people and communities where we work. This film lets you know more about how.
Views: 212389 IKEA USA
Webinar: Intro to the Product Development Protocol (Part 1, FDA Series)
 
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(1st of 4-part series) Jeff Skiba addresses various components of FDA product development protocol such as product strategy, design and development, verification and validation, launch plan, design transfer and production.http://asbtdc.org - Subscribe Now! https://www.youtube.com/subscription_center?add_user=ArkansasSBTDC The Arkansas Small Business and Technology Development Center is funded in part through a cooperative agreement with the U.S. Small Business Administration. All opinions, conclusions or recommendations expressed are those of the author(s) and do not necessarily reflect the views of the SBA. All ASBTDC programs are extended to the public on a non-discriminatory basis.
Views: 159 ArkansasSBTDC
Medical Device Design Control: Understanding Complexity, Importance, and the Risks
 
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Click here for more Information https://www.audioeducator.com/pharma-biotech/medical-device-design-controls-process-regulations.html Medical Device Design Control: Understanding Complexity, Importance, and the Risks Presented By: Charles Paul Join this session, where expert speaker Charles H. Paul will explore how design controls should be designed to meet both the spirit and intent of the regulation and the needs of both the medical device itself and your organization. More Videos: - http://www.youtube.com/user/audioeducator2 You can also connect with us on Twitter, Facebook, Google+ and LinkedIn and get the most updated news and views, expert advice and tips to help resolve your coding, billing & compliance dilemmas quickly and accurately. Connect with us on Twitter: - https://twitter.com/audioeducator Facebook: - https://www.facebook.com/pages/AudioEducator/244912592201260 LinkedIn: - http://www.linkedin.com/company/audio-educator Google+: - https://plus.google.com/102668946943256059069/posts
Views: 77 AudioEducator
Polarion Medical Device Intelligent Design Control
 
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This webinar series is an in-depth overview of “Intelligent Design Control” in Mechatronic Medical Devices utilizing Polarion ALM. Each webinar will take a different look at key features that streamline and automate the process, and maintain critical traceability throughout with building an electronic Design History File (eDHF) including: Incorporating standards and regulations sources into Design Control Risk analysis and mitigation – ISO-14971 “harms down” inclusion into Design Control Design verification & validation protocols, execution, and report evidence The series will show how to optimize and digitze your Risk Management process and incorporate it directly into the traceability of the Intelligent Design Control. Moving forward, we will demonstrate how testing features in Polarion answer the multiple demands of verification and validation throughout a complex design control process, with necessary evidence for the DHF. Polarion is a portable framework capable of mirroring any design methodology and workflow or process. It can be rapidly implemented in an incremental manner so groups are brought into the process while fostering adoption. The results of which are a collaborative approach that will ensure your development, quality/testing efforts are more efficient and cohesive. Bottom-line a unified solution for software development will reduce your cycles and time to market. Join us for this complimentary 40-60 minute webinar to discover the benefits of a software platform that will provide you a multidimensional, traceability solution for complex development environments. ​
User Needs and the Disconnect in Medtech Product Development
 
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Craig Scherer, co-founder and senior partner at Insight Product Development, discusses the challenges that medical device companies face in identifying using needs and the implementation process with MedTech Intelligence.
Filament PD uses Fusion 360 as a comprehensive product development solution
 
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Filament PD, a product development company in Glasgow on their transition to Fusion 360 as a comprehensive product development solution. Head over to www.filamentpd.com to see some more examples of projects designed on Fusion 360. ► Get Fusion 360 | http://autode.sk/11CfIDv SUBSCRIBE | http://autode.sk/11vxXeD FACEBOOK | http://autode.sk/19jII5A TWITTER | http://autode.sk/19jIJXc GET STARTED | http://autode.sk/2tA5QMg
Views: 2806 Autodesk Fusion 360
Medical Device Design for Consumer Health
 
01:19:17
http://MedicalDevicesGroup.net Tom KraMer, Medical Devices Group Advisory Board member, and Mark Schwartz, CEO of Product Development Technologies (PDT) discuss: • How consumer vital tracking and clinical grade devices are converging • The issues developing these devices and how they’ve been solved in past development programs • The four types of connectivity solutions by level of complexity • How to decide which device type and development route is best for your application RELEVANT FOR: • Anyone tasked with the creation of connected solutions for patient monitoring, scheduling, tracking, or drug delivery • Those interested in how consumer electronic technologies can be used in health and medical solutions • Product, project and R&D directors, managers, designers, marketers, and engineers
Views: 266 MedicalMarcom

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