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Biotronik’s EU MDR Certification a ‘Huge Milestone’, Says GlobalData

By MedTech Intelligence Staff

Register to attend the EU MDR Implementation Strategies Virtual Conference | February 4–6, 2020This week Biotronik received the first EU MDR certification for a Class III medical device. The certification…

Register to attend the EU MDR Implementation Strategies Virtual Conference | February 4–6, 2020This week Biotronik received the first EU MDR certification for a Class III medical device. The certification…

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Sandi Schiable, WuXi AppTec
Soapbox

Preparing for MDR: Partner Up

By Sandi Schaible

Medical device manufacturers are under serious pressure to get in gear and conduct their pre-clinical device testing—and fast. Europe’s Medical Device Regulation (MDR) will require submissions to be approved by…

Medical device manufacturers are under serious pressure to get in gear and conduct their pre-clinical device testing—and fast. Europe’s Medical Device Regulation (MDR) will require submissions to be approved by…

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MedTech Intelligence

Top 10 Articles of Summer 2019

By MedTech Intelligence Staff

…to share the most popular articles of the season. Enjoy! #10 https://www.medtechintelligence.com/feature_article/trends-in-medical-device-recalls/ #9 https://www.medtechintelligence.com/news_article/udi-implementation-progress-challenges-where-we-are-now/ #8 https://www.medtechintelligence.com/column/regulating-ai-based-medical-devices-a-moving-target/ #7 https://www.medtechintelligence.com/column/eumdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ #6 https://www.medtechintelligence.com/column/eumdr-udi-and-master-data-how-to-ensure-label-compliance/ #5 https://www.medtechintelligence.com/news_article/following-two-deaths-teleflex-medical-recalls-more-than-six-million-endotracheal-tubes-and-connectors/ #4 https://www.medtechintelligence.com/column/eumdr-changing-world-of-classification/ #3 https://www.medtechintelligence.com/column/eumdr-post-market-surveillance-active-integrated-risk-based-and-planned/ #2 https://www.medtechintelligence.com/feature_article/preparing-for-mdr-dont-forget-about-class-i-reusable-devices/ #1 https://www.medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/…

…to share the most popular articles of the season. Enjoy! #10 https://www.medtechintelligence.com/feature_article/trends-in-medical-device-recalls/ #9 https://www.medtechintelligence.com/news_article/udi-implementation-progress-challenges-where-we-are-now/ #8 https://www.medtechintelligence.com/column/regulating-ai-based-medical-devices-a-moving-target/ #7 https://www.medtechintelligence.com/column/eumdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ #6 https://www.medtechintelligence.com/column/eumdr-udi-and-master-data-how-to-ensure-label-compliance/ #5 https://www.medtechintelligence.com/news_article/following-two-deaths-teleflex-medical-recalls-more-than-six-million-endotracheal-tubes-and-connectors/ #4 https://www.medtechintelligence.com/column/eumdr-changing-world-of-classification/ #3 https://www.medtechintelligence.com/column/eumdr-post-market-surveillance-active-integrated-risk-based-and-planned/ #2 https://www.medtechintelligence.com/feature_article/preparing-for-mdr-dont-forget-about-class-i-reusable-devices/ #1 https://www.medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/…

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Peter Rose, Maetrics
Soapbox

EU MDR: Changing World of Classification

By Peter Rose

EU. Specifically, Class I manufacturers should be aware that following publication of the EU MDR in 2017 a three-year transition period commenced, at which point all manufacturers of medical devices…

EU. Specifically, Class I manufacturers should be aware that following publication of the EU MDR in 2017 a three-year transition period commenced, at which point all manufacturers of medical devices…

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Josh Roffman, Loftware
MEDdesign

EU MDR, UDI and Master Data: How to Ensure Label Compliance

By Josh Roffman

The 2017 European Union Medical Device Regulation (MDR) deadline of May 26, 2020 is fast approaching. Beyond UDI, the EU MDR has additional regulatory requirements, and the device compliance categories…

The 2017 European Union Medical Device Regulation (MDR) deadline of May 26, 2020 is fast approaching. Beyond UDI, the EU MDR has additional regulatory requirements, and the device compliance categories…

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UDI Implementation: Progress, Challenges, Where We Are Now

By Maria Fontanazza

MDR requires all devices to be fully traceable through a UDI system, so device manufacturers must be on top of labeling processes. EU MDR Implementation Strategies (A Virtual Event) |…

MDR requires all devices to be fully traceable through a UDI system, so device manufacturers must be on top of labeling processes. EU MDR Implementation Strategies (A Virtual Event) |…

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Top 10: EU MDR Remains a Hot Topic in 2019

The following are the top 10 most popular articles so far this year. #10 https://www.medtechintelligence.com/feature_article/new-eumdr-regulations-revamp-medical-device-directive/ #9 https://www.medtechintelligence.com/news_article/misconceptions-of-eumdr-implementation/ #8 https://www.medtechintelligence.com/column/eumdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ #7 https://www.medtechintelligence.com/news_article/first-step-in-eumdr-compliance-the-gap-analysis/ #6 https://www.medtechintelligence.com/column/eumdr-post-market-surveillance-active-integrated-risk-based-and-planned/ #5 https://www.medtechintelligence.com/news_article/another-eto-medical-device-sterilizer-to-close-due-to-environmental-quality-issues/ #4 https://www.medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/ #3 https://www.medtechintelligence.com/news_article/nightline-broadcasts-previously-unseen-footage-of-elizabeth-holmes-deposition-in-report-about-ceo-and-fall-of-theranos/ #2…

The following are the top 10 most popular articles so far this year. #10 https://www.medtechintelligence.com/feature_article/new-eumdr-regulations-revamp-medical-device-directive/ #9 https://www.medtechintelligence.com/news_article/misconceptions-of-eumdr-implementation/ #8 https://www.medtechintelligence.com/column/eumdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ #7 https://www.medtechintelligence.com/news_article/first-step-in-eumdr-compliance-the-gap-analysis/ #6 https://www.medtechintelligence.com/column/eumdr-post-market-surveillance-active-integrated-risk-based-and-planned/ #5 https://www.medtechintelligence.com/news_article/another-eto-medical-device-sterilizer-to-close-due-to-environmental-quality-issues/ #4 https://www.medtechintelligence.com/feature_article/iq-oq-pq-backbone-quality-system/ #3 https://www.medtechintelligence.com/news_article/nightline-broadcasts-previously-unseen-footage-of-elizabeth-holmes-deposition-in-report-about-ceo-and-fall-of-theranos/ #2…

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Luke Moran, Aerotek
Soapbox

Growth in Medical Devices Spurs Recruitment Challenges

By Luke Moran

…products to adhere to the new EU MDR, which means going back through legacy products and updating them to be compliant. The new regulations have made the approval process more…

…products to adhere to the new EU MDR, which means going back through legacy products and updating them to be compliant. The new regulations have made the approval process more…

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David Gwyn, Amplexor
Soapbox

Regulatory Reporting: What can Medical Device Manufacturers Learn from Big Pharma?

By David Gwyn

…confined to the manufacturing shop floor. But all that will need to change in the run-up to the European Commission’s new medical device regulation (MDR), applicable from May 2020, and…

…confined to the manufacturing shop floor. But all that will need to change in the run-up to the European Commission’s new medical device regulation (MDR), applicable from May 2020, and…

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