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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: February 18–19, 2020 Topics include ISO 14971:2019 overview and applicability to EU MDR and other regions; design and usability requirements; post…

drug device combination products. EU MDR Risk Management When: February 18–19, 2020 Topics include ISO 14971:2019 overview and applicability to EU MDR and other regions; design and usability requirements; post…

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Jon Speer, Greenlight Guru
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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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Sue Spencer, IVD, EU MDR, Qserve
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IVDR: Go with the Flow

By Sue Spencer

…1. Regulation (EU) 2017|746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU….

…1. Regulation (EU) 2017|746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU….

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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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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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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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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
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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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