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.
February 05, 2021

FAQ Friday with Amé Huige: answers to your questions regarding UK registration for custom-made devices

In this weeks vlog, Amé answers questions regarding UK registration for custom-made devices
Tags
January 22, 2021

FAQ Friday with Giovanni: answers to your questions about vigilance and incident reporting

In this weeks vlog, Giovanni answers the question: Does it mean that if a certain type of serious incident has been listed in the IFU and assessed in the risk management as acceptable, then it is not to be reported? Even if it has a causal relationship with the device?
Tags
January 08, 2021

FAQ Friday with Amé Huige: answers to your questions about EUDAMED training

In this weeks vlog, Amé answers your questions about training on EUDAMED
Tags
December 18, 2020

FAQ Friday Special Edition with Páll Jóhannesson: answers to your questions regarding PMCF Surveys

This week's FAQ Friday we are teaming up with Páll Jóhannesson from SMART-TRIAL because who knows more about surveys than Páll?
Tags
December 11, 2020

FAQ Friday with Stefan Menzl: answers to your questions about importer labelling and PMCF surveys

In this weeks vlog, Stefan answers questions regarding importer labelling and PMCF surveys
Tags
December 04, 2020

FAQ Friday with Henk-Willem Mutsaers: answers to your questions about common area/topics that are misses from MDR internal audits

In this weeks vlog, Henk-Willem answers questions about common area/topics that are misses from MDR internal audits
Tags
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.
Tags
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.
Tags
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.
Tags
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)
Tags
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
Tags
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!
Tags
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
Tags
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?
Tags
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
Tags
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.
Tags
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.
Tags
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?
Tags
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?
Tags
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?
Tags
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
Tags
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.
Tags
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.
Tags
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?
Tags
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?
Tags
How can we help you? Contact us