Remco Munnik, Iperion
Soapbox

Capitalizing on Standardized International Product Data

By Remco Munnik

…the two resources could make it easier to spot relative product shortages versus availability between different EU markets. Traceability of products is also the major thrust of the new MDR

…the two resources could make it easier to spot relative product shortages versus availability between different EU markets. Traceability of products is also the major thrust of the new MDR

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Adrienne Lovink, Decision Resources Group
Soapbox

2020 Business Outlook: Five Macrotrends Changing the Way Medtech Does Business

By Adrienne Lovink, Lexie Code, Zaid Al-Nassir

…these drivers will be saliently evident, whether through the implementation of the MDR in Europe, the expected ratification of the USMCA in North America, the continued execution of Ayushman Bharat…

…these drivers will be saliently evident, whether through the implementation of the MDR in Europe, the expected ratification of the USMCA in North America, the continued execution of Ayushman Bharat…

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Justice scale, healthcare, cost

Will the 2020 Elections Affect MedTech Investment? Maybe

By Maria Fontanazza

…drive the diagnostics market Robotic surgery remains attractive for M&A Devices that integrate artificial intelligence The regulatory environment continues to evolve, taking into consideration EU MDR/IVDR and changes to FDA…

…drive the diagnostics market Robotic surgery remains attractive for M&A Devices that integrate artificial intelligence The regulatory environment continues to evolve, taking into consideration EU MDR/IVDR and changes to FDA…

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European Union Flag

EU MDR: Will You Be Able to Sell Your Medical Device in Europe after May 26?

By MedTech Intelligence Staff

…drug device combination products. EU MDR Risk Management When: April 2020 Topics include ISO 14971:2019 overview and applicability to EU MDR and other regions; design and usability requirements; post market…

…drug device combination products. EU MDR Risk Management When: April 2020 Topics include ISO 14971:2019 overview and applicability to EU MDR and other regions; design and usability requirements; post market…

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Jon Speer, Greenlight Guru
Soapbox

4 Keys to Funding Your Medical Device

By Jon Speer

…in place like ISO 13485:2016 and EU MDR and not to mention the ones coming shortly like the third revision to ISO 14971. Regulatory changes will only continue to occur…

…in place like ISO 13485:2016 and EU MDR and not to mention the ones coming shortly like the third revision to ISO 14971. Regulatory changes will only continue to occur…

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Checkbox

Top MedTech Articles of 2019

By MedTech Intelligence Staff

#10 https://www.medtechintelligence.com/column/eumdr-changing-world-of-classification/ #9 https://www.medtechintelligence.com/feature_article/five-steps-medical-device-commercialization/ #8 https://www.medtechintelligence.com/news_article/nightline-broadcasts-previously-unseen-footage-of-elizabeth-holmes-deposition-in-report-about-ceo-and-fall-of-theranos/ #7 https://www.medtechintelligence.com/feature_article/new-eumdr-regulations-revamp-medical-device-directive/ #6 https://www.medtechintelligence.com/feature_article/trends-in-medical-device-recalls/ #5 https://www.medtechintelligence.com/news_article/first-step-in-eumdr-compliance-the-gap-analysis/ #4 https://www.medtechintelligence.com/news_article/cdrh-warns-of-potential-device-shortage-with-shutdown-of-sterigenics-facility-in-illinois/ #3 https://www.medtechintelligence.com/column/eumdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ #2 https://www.medtechintelligence.com/column/eumdr-post-market-surveillance-active-integrated-risk-based-and-planned/ #1 https://www.medtechintelligence.com/feature_article/preparing-for-mdr-dont-forget-about-class-i-reusable-devices/…

#10 https://www.medtechintelligence.com/column/eumdr-changing-world-of-classification/ #9 https://www.medtechintelligence.com/feature_article/five-steps-medical-device-commercialization/ #8 https://www.medtechintelligence.com/news_article/nightline-broadcasts-previously-unseen-footage-of-elizabeth-holmes-deposition-in-report-about-ceo-and-fall-of-theranos/ #7 https://www.medtechintelligence.com/feature_article/new-eumdr-regulations-revamp-medical-device-directive/ #6 https://www.medtechintelligence.com/feature_article/trends-in-medical-device-recalls/ #5 https://www.medtechintelligence.com/news_article/first-step-in-eumdr-compliance-the-gap-analysis/ #4 https://www.medtechintelligence.com/news_article/cdrh-warns-of-potential-device-shortage-with-shutdown-of-sterigenics-facility-in-illinois/ #3 https://www.medtechintelligence.com/column/eumdr-supplier-quality-requirements-convergence-of-best-practice-and-regulation/ #2 https://www.medtechintelligence.com/column/eumdr-post-market-surveillance-active-integrated-risk-based-and-planned/ #1 https://www.medtechintelligence.com/feature_article/preparing-for-mdr-dont-forget-about-class-i-reusable-devices/…

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Sandi Schiable, WuXi AppTec

Q&A: MedTech Industry Still Scrambling as MDR Deadline Nears

By Maria Fontanazza

As preparation for compliance with EU MDR should be well underway at most companies that market products in Europe, there is continued buzz about manufacturers being behind the eight ball….

As preparation for compliance with EU MDR should be well underway at most companies that market products in Europe, there is continued buzz about manufacturers being behind the eight ball….

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magnifying glass

Survey: 75% MedTech Pros Unprepared for an Unannounced FDA or Notified Body Audit

By MedTech Intelligence Staff

…unannounced audit by FDA or Notified Body Only 20% of these folks are prepared for an EU MDR audit Challenges to improving product development processes include: Resource constraints: 55% Lack…

…unannounced audit by FDA or Notified Body Only 20% of these folks are prepared for an EU MDR audit Challenges to improving product development processes include: Resource constraints: 55% Lack…

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Technology hazards in hospirals, ECRI

Injury and Death from Surgical Staplers Preventable, Product Misuse Tops ECRI’s 2020 Technology Hazards List

By MedTech Intelligence Staff

…involving the products had climbed. FDA combined MAUDE and ASR (the alternative summary reporting program, which has since been shuttered by the agency) MDR reports, and stated that the number…

…involving the products had climbed. FDA combined MAUDE and ASR (the alternative summary reporting program, which has since been shuttered by the agency) MDR reports, and stated that the number…

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European Union Flag

How Are Medical Device Companies Addressing EU MDR?

By Laura Johnson

…that label and packaging artwork processes play in meeting compliance for EU MDR. MedTech Intelligence: In what areas under EU MDR do you see manufacturers facing the most challenges in…

…that label and packaging artwork processes play in meeting compliance for EU MDR. MedTech Intelligence: In what areas under EU MDR do you see manufacturers facing the most challenges in…

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