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FDA

Medical Device Innovation

Enlil Focuses on Accelerating Medical Device Innovation with Compliance

We were recently alerted to a company we weren’t covering because a long-time business friend took a key position there. After a quick review of what they do, Julie Fraser and Jim Brown decided to team up on the briefing because we could already see a combination of QMS and PLM capabilities. We learned that…

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  • Insights

Jim Brown - May 12, 2025 - Filed Under: Insights, Insights & Activity - Tagged With: Medical Device, Traceability, Approval, FDA, Compliance, MedTech, PLM, Class 2, Product Development, Class 3, Manufacturing, Clearance, NPD, Quality Management, Product Innovation

Predictive Quality

Predictive Quality for Medical Devices (eBook)

Could medical device companies improve both patient outcomes and profit? Yes, and Predictive Quality for Medical Devices: Comprehensive Data to Move Risk-based Approaches into Production discusses how to modernize the quality system for best results. The predictive approach to quality is proactive and requires strong manufacturing data management. The report includes insights from executives at…

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  • eBooks

Julie Fraser - July 19, 2021 - Filed Under: eBooks, Published Research - Tagged With: Predictive Quality, Medical Device Manufacturing, EUDMR, Medical Devices, Quality System, FDA, Manufacturing Data

Medical Device Manufacturers’ Software

Medical Device Manufacturers’ Software Selection Guide

What should you think about when selecting a software solution to support the development of medical devices while considering the Case for Quality and the EU MDR? Tech-Clarity’s Medical Device Manufacturers’ Software Selection Guide helps manufacturers identify the right buying criteria for software solutions to support developing, producing, and servicing medical devices. The guide also…

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  • White Papers

Michelle Boucher - April 17, 2020 - Filed Under: White Papers, Buyer's Guides, Published Research - Tagged With: NPD, IoT, Quality Management, Internet of Things, CAPA, Augmented Reality, Regulations, AR, Medical Device, FDA, 3D Printing, Case for Quality, Requirements, ISO 13485, Compliance, Embedded Software, UDI, PLM, Healthcare, EU MDR, Product Development, Criteria, ALM, Buyer's Guide, Medical Design Regulation

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

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