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Compliance

EU MDR

EU MDR: How Abbott is Getting Their Digital House In Order (webcast)

If you are in the medical device industry, are you prepared for the EU MDR? In this on-demand webcast, Tech-Clarity’s Michelle Boucher interviews Caroline Byrd, regulatory expert at Abbott, about the steps Abbott has taken to prepare product data for EU MDR compliance. They discuss: Significant changes between the MDD and MDR How to prioritize…

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  • Webinars

Michelle Boucher - November 1, 2018 - Filed Under: Webinars, Presentations & Videos - Tagged With: ALM, MDD, Medical Device, Medical Device Regulation, Webcast, EUDAMED, Webinar, Regulation, Traceability, Cost of Compliance, Engineer, Compliance, Single Source of Truth, PLM, Abbott, PTC, EU MDR

Medical Devices

Medical Devices Manufacturers Software Selection Guide for 2018

Thank you for your interest in the Medical Devices Manufacturers Software Selection Guide for 2018  Buyer’s Guide! Please enjoy complimentary access from our sponsor, PTC. 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…

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    Jim Brown - October 31, 2018 - Filed Under: Hidden - Tagged With: NPD, Internet of Things, Quality Management, FDA, CAPA, Case for Quality, Regulations, ISO 13485, Medical Device, UDI, Requirements, Embedded Software, Compliance, Healthcare, PLM, Criteria, Product Development, Buyer's Guide, ALM, IoT

    How Roche Diabetes Care Is Winning at PLM, Quality, and Compliance (webcast)

    How can medical device companies balance quality, innovation, compliance, and profitability? Where does a PLM solution fit in? Is it possible to achieve a single source of truth? Listen to Claus Gärtner, Head of Operations & Quality IT at Roche Diabetes Care, René Zoelfl PTC Life Sciences Development Manager, and  Tech-Clarity’s Michelle Boucher discuss how to support the…

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    • Webinars

    Michelle Boucher - May 2, 2018 - Filed Under: Webinars, Presentations & Videos - Tagged With: IoT, Compliance, Engineer, PLM, FDA, PTC, Smart Connected Products, ALM, Roche Diabetes Care, Medical Device, Single Source of Truth, Webcast, Webinar, Regulation, Traceability, Cost of Compliance

    PLM Medical Device

    How Boston Scientific Selected their PLM Medical Device Software Solution (webcast)

    Does having multiple systems to manage product information create challenges for your company? Do you find some systems are so heavily customized, it’s hard to take advantage of the latest software enhancements? How can a PLM medical device solution help? If you have thought about any of these questions, you will find this webinar especially…

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    • Webinars

    Michelle Boucher - March 7, 2018 - Filed Under: Presentations & Videos, Webinars - Tagged With: Regulation, Traceability, Cost of Compliance, IoT, Compliance, Engineer, PLM, FDA, PTC, Smart Connected Products, ALM, Boston Scientific, Medical Device, Unified PLM, Webcast, Webinar

    Digitalization in the Medical Device Industry (animation)

    How can digitalization help medical device companies improve innovation and drive profitable growth despite increased complexity and regulatory scrutiny? This animated video offers a look at what a digital medical device company looks like and offers three initiatives companies can adopt to start their digital transformation. Digitalization offers significant benefits to medical device manufacturers because…

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    • Animations

    Jim Brown - February 28, 2018 - Filed Under: Animations, Presentations & Videos - Tagged With: Digital Design Transfer, MES, Paperless Manufacturing, Medical Device, MOM, Animation, Compliance, Vlog, Tech-Clarity TV, Digitalization, Video, Med Device, Innovation, Digital Enterprise, Siemens PLM, Digital Design, Quality, Digital Design Control, Time to Market

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

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