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FDA

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

Medical Device Manufacturers’ Software

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

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: ALM, Buyer's Guide, CAPA, Case for Quality, Compliance, Criteria, Embedded Software, FDA, Healthcare, Internet of Things, IoT, ISO 13485, Medical Device, NPD, PLM, Product Development, Quality Management, Regulations, Requirements, UDI

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

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

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

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