FAQ

FAQ - Frequently Asked Questions

FAQ

Frequently Asked Questions

Below you'll find answers to the questions we get asked the most about Market Access Europe for Medical Devices and IVDs but also about  FDA, NMPA and Global market access. If you have a question for one of our experts, send a mail to FAQfriday@@qservegroup.com.
November 27, 2020

FAQ Friday with Sue Spencer: answers to your questions about IVDR Classification Guidance | part 2

In this weeks vlog, Sue Spencer guides you through the IVDR Classification guidance.
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November 20, 2020

FAQ Friday with Sue Spencer: answers to your questions about IVDR Classification Guidance | part 1

In this weeks vlog, Sue Spencer guides you through the IVDR Classification guidance.
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November 13, 2020

FAQ Friday with Gert Bos, answers to your questions regarding residual risks

In this weeks vlog, Gert Bos answers questions regarding residual risks.
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November 06, 2020

FAQ Friday with Wiebe Postma: answers to your questions about PMCF, class l devices and Article 61(10)

In this weeks vlog Wiebe Postma answers your questions about PMCF, class l devices and Article 61(10)
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October 30, 2020

FAQ Friday with Stefan Menzl: answers to your questions about changes to MDD devices

In this weeks vlog Stefan Menzl answers to your questions about changes to MDD devices
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October 23, 2020

FAQ Friday with Max van Regteren: answers to your questions about European Authorized Representatives (EAR)

What is a European Authorized Representative? Why do you need one? What are their responsibilities and can I sell my medical devices all over Europe once I have a European Authorized Representative? 🔎 This week's FAQ Friday, Max van Regteren will answer all above questions!
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October 16, 2020

FAQ Friday with Jan-Paul van Loon: answers to your questions about 3D printing

In this weeks vlog, Jan-Paul van Loon answers to your questions about 3D printing
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October 09, 2020

FAQ Friday Special Edition with Bassil Akra: answers to your questions about Notified Bodies

This week's FAQ Friday we are teaming up with Bassil Akra from QUNIQUE because who knows more about Notified Bodies than Bassil?
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October 02, 2020

FAQ Friday with Jan van Lochem: answers to your questions about clinical data for existing devices

In this weeks vlog, Jan van Lochem answers to your questions about clinical data for existing devices
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September 25, 2020

FAQ Friday with Sue Spencer: answers to your questions about MHRA Brexit Guidance | part 2

In this weeks vlog, Sue Spencer guides you through the MHRA BREXIT guidance.
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September 18, 2020

FAQ Friday with Sue Spencer: answers to your questions about MHRA Brexit Guidance | part 1

In this weeks vlog, Sue Spencer guides you through the MHRA BREXIT guidance.
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September 11, 2020

FAQ Friday Special Edition with Erik Vollebregt: answers to your question about legal representation

This week's FAQ Friday we are teaming up with Erik Vollebregt from Axon Lawyers because who knows more about legal representation than Erik?
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September 04, 2020

FAQ Friday: Answers to your questions about confidentiality during remote audits

In this weeks vlog, Henk-Willem Mutsaers answers the question: how are new confidentiality and security concerns being addressed in remote audits?
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August 28, 2020

FAQ Friday: Answers to your questions about China legal agent

In this weeks vlog, Michael Yan answers the question: what are the requirements of China Legal Agent (or China Authorized Representative)? And what are their rights and obligations?
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August 21, 2020

FAQ Friday: Answers to your questions about remote audits after COVID

In this weeks FAQ Friday vlog, Henk-Willem Mutsaers answers questions about remote audits after COVID-19
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August 07, 2020

FAQ Friday: Answers to your questions about PMCF and PSURs

In this weeks FAQ Friday vlog, Giovanni di Rienzo answers questions about PMCF and PSURs.
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July 31, 2020

FAQ Friday: Answers to your questions about US agent

In this weeks vlog, Max van Regteren answers multiple questions about US agent.
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July 24, 2020

FAQ Friday: Answers to your questions about Annex II requirements of the MDR

In this weeks vlog, Jan Paul van Loon answers the question: when completing this part of the technical documentation should we only refer to outward facing documents and not to internal documents such as design inputs?
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July 17, 2020

FAQ Friday: Answers to your questions about software registration in China

This is already our 20st FAQ Friday and we want to celebrate it with a not often discussed subject. In this weeks vlog, Michael Yan answers the question: what are the requirements of versioning rules of medical device Software registration in China?
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July 10, 2020

FAQ Friday: Answers to your questions about PRRC

In this weeks vlog, Peter Reijntjes answers the question if the role of PRRC needs to be established and implemented at DoA when a manufacturer makes use of the transitional provisions.
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July 03, 2020

FAQ Friday: Answers to your questions about clinical investigation for class lll devices

In this weeks vlog, Jasmin Hunter answers the question if you can certify legacy class lll devices under the MDR without doing a clinical investigation.
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June 26, 2020

FAQ Friday: Answers to your questions about sample size for clinical investigation

In this weeks vlog, Claire Cox answers questions about how to determine sample sizes. 
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June 19, 2020

FAQ Friday: Answers to your questions about PMCF activities

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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May 22, 2020

FAQ Friday: Answers to your questions about China submission

This week Stephanie Huang answers questions about China submission.
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May 08, 2020

FAQ Friday: Answers to your questions about Clinical Development Plans and Strategies

This week Diana Nogueira answers questions about clinical development plans and strategies.
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