Qserve's Highlights

Qserve's Highlights

Hot topics from the month of June

Each day our Qserve experts share in-depth content on our website and LinkedIn page. These posts are most popular with our readers. If you want to receive this update in your mailbox, click here and stay up to date!

 

Qserve's June Highlights

June 22, 2020

Transitional provisions for legacy devices incorporating a medicinal product or tissue of animal origin (MDCG 2020-12)

The lack of any grandfathering provisions is one of the biggest hurdles the MDR has put in front of manufacturers willing to transition their devices to the new legislative regime, and probably to the entire system, including Notified Bodies and national competent authorities.
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June 19, 2020

FAQ Friday: Answers to your questions about PMCF activities

We are very excited about the many FAQ Friday questions we have received in the past months. Hopefully, you appreciate our expert vlogs and the answers were helpful. 🔎 In this weeks vlog, Loes Pelgrim answers questions about PMCF activities. Do you also have questions for one of our experts? Feel free to email us at FAQfriday@qservegroup.com.
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June 18, 2020

Updates to FDA’s COVID-19 Test EUA Templates for Asymptomatic Screening, Pooled Samples & Home Collection

Continuing our series covering market access requirements for COVID-19 tests, the FDA remains diligent in communicating their performance expectations for COVID-19 tests marketed by laboratories and manufacturers in the U.S.w.
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June 15, 2020

The role of PRRC under the transitional provisions – a mystery unresolved?

One of the most frequently asked questions related to the Person Responsible for Regulatory Requirements is if that role must be established and implemented at date of application of the EU MDR and EU IVDR for those organizations which make use of the ‘transitional provisions’? 
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June 04, 2020

Usability of Unknown Provenance (UOUP)

Medical devices have been required to integrate usability engineering principles and user interface design characteristics into their safety design and development process within the last 20 years since medical device risk management introduced the concept of user error in the 2000 version of IEC 14971 (annex A).

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