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CAPA

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

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

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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Michelle Boucher - January 30, 2018 - Filed Under: Buyer's Guides, Published Research - 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

Putting the Q in PLM (PTC does quality management)

I had the chance to talk with … PTC about the important role that PLM plays in ensuring product quality. PTC shared their views on quality and reliability and followed up by giving me some detailed insight into their Relex reliability management solution and how it fits into the PLM ecosystem. It turns out PTC…

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Jim Brown - February 24, 2011 - Filed Under: Clarity on PLM, Insights, Insights & Activity - Tagged With: CAPA, One-to-One, PLM, PTC, QLM, QMS, Quality, Quality Planning, Relex, Reliability

Quality Risk Management in Life Sciences

Tech-Clarity’s new report Quality Risk Management in Life Sciences: Preventing Failures, Protecting Patient Health reviews manufacturers’ experiences in using Quality Risk Management (QRM) to proactively reduce risk in the Life Sciences industries. Explains how QRM software can be used to efficiently manage risk by sharing quality knowledge across the enterprise and closing the loop on product…

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Jim Brown - August 31, 2010 - Filed Under: Published Research - Tagged With: CAPA, Clinicial Trials, FMEA, Insight, Life Sciences, Medical Device, Medical Equipment, Moll Industries, Patient Health, PLM, QLM, QRM, Quality, Quality Risk Management, Roche

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