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Compliance

Digital Design Control for Medical Devices

Medical Device companies have to manage complexity and regulation without placing excess overhead on their designers. Devices complexity has led to increased complaints, CAPAs, observations, and recalls. The root cause is frequently insufficient and cumbersome design control. Digitalization helps them design with agility while maintaining control. It improves speed, accuracy, and productivity by automating submissions,…

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  • Tech-Clarity TV

Jim Brown - February 20, 2018 - Filed Under: Presentations & Videos, Tech-Clarity TV, Video - Tagged With: Quality, FDA, CAPA, Med Device, Device Master Record, Digital Enterprise, DMR, Digital Design, Medical Device, Digital Design Control, Traceability, Submissions, Compliance, Vlog, Observations, Tech-Clarity TV, Digitalization, Recalls, Video, Product Innovation Platform, Innovation, Design History File, Siemens PLM, DHF

The Digitalization Opportunity for Medical Device Companies (video)

Medical Device companies have the opportunity to leverage digitalization and the digital enterprise to develop innovative products and bring them to market quickly. Watch this edition of Tech-Clarity TV to learn about the digitalization opportunity and stay tuned for the rest of the series detailing specific business improvement opportunities including: Digital design Digital design transfer…

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  • Tech-Clarity TV

Jim Brown - January 31, 2018 - Filed Under: Video, Presentations & Videos, Tech-Clarity TV - Tagged With: Digital Design Control, Quality, Digital Design Transfer, Time to Market, Paperless Manufacturing, MES, Medical Device, MOM, Vlog, Compliance, Digitalization, Tech-Clarity TV, Med Device, Video, Digital Enterprise, Innovation, Digital Design, Siemens PLM

Medical Devices

Medical Devices Manufacturers Software Selection Guide for 2018

Tech-Clarity’s Medical Devices Manufacturers Software Selection Guide for 2018 helps manufacturers identify the right buying criteria for software solutions to support developing, producing, and servicing medical devices. For 2018, the guide has also been updated to include additional considerations for the Internet of Things (IoT). This buyer’s guide also takes into account unique needs for medical device…

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  • Buyer's Guides

Michelle Boucher - January 30, 2018 - Filed Under: Published Research, Buyer's Guides - Tagged With: Regulations, ISO 13485, Medical Device, UDI, Requirements, Embedded Software, Compliance, Healthcare, PLM, Criteria, Product Development, Buyer's Guide, ALM, IoT, NPD, Internet of Things, Quality Management, FDA, CAPA, Case for Quality

How to Beat Your Competition in Product Development (infographic)

This infographic shares our research on how Top Performing companies achieve better NPDI performance than their competitors, excelling at revenue growth, margin expansion, and delivering innovative products. The infographic starts by providing a graphical view of the unfortunate truth about new product development, companies miss their quality, cost, requirements, regulatory compliance, project budget, and time…

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  • Infographics

Jim Brown - October 31, 2017 - Filed Under: Published Research, Infographics - Tagged With: New Product Development, Targets, NPD, Quality, Time to Market, Cost, Best Practices, Systems, Benchmark, Budget, Compliance, Infographic, Product Development, NPDI

Medical Devices

Medical Devices in a Digital World (podcast)

Listen to Michelle Boucher discuss trends in the Medical Device Industry in this 17 minute podcast, Medical Devices in a Digital World. This podcast is episode 8 of The Connected Engineer series with Gavin Quinlan. In this episode, Michelle explains some of the top challenges facing medical device companies. She also shares advice on how to overcome them….

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    Michelle Boucher - October 19, 2017 - Filed Under: Presentations & Videos - Tagged With: Podcast, Regulation, Traceability, Cost of Compliance, IoT, Engineer, FDA, Compliance, Case for Quality, PLM, Smart Connected Products, PTC, Medical Device

    Medical Device Engineering

    Selecting the Right PLM Software for Medical Device Engineering (webcast)

    Listen to Tech-Clarity’s Michelle Boucher, Mark Turner from Alcon Labs (Novartis), and Swapan Jha from PTC have a discussion on the right software solution for medical device engineering. The discussion featured an interactive discussion between the panelists coving topics such as: Challenges facing medical device manufacturers. Why to consider the complete product lifecycle with respect…

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    • Webinars

    Michelle Boucher - September 11, 2017 - Filed Under: Presentations & Videos, Webinars - Tagged With: IoT, Compliance, Engineer, PLM, FDA, PTC, Smart Connected Products, ALM, Medical Device, Webcast, Webinar, Regulation, Traceability, Cost of Compliance

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