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.
July 10, 2020

FAQ Friday: Answers to your questions about PRRC

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. πŸ”Ž 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.
July 03, 2020

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

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.πŸ”Ž 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.
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. πŸ”Ž 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.
June 12, 2020

FAQ Friday: Answers to your questions about evidence for long term implants

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. πŸ”Ž In this weeks vlog, Gert Bos answers questions about the evidence for long term implants.
June 05, 2020

FAQ Friday: Answers to your questions about Summary of Safety and Performance for IVDR devices

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. πŸ”Ž In this weeks vlog, Sue Spencer answers questions about the SSP for IVDR devices.
May 29, 2020

FAQ Friday: Answers to your questions about responsibilities of Economic Operators

We know there are a lot of questions regarding new regulations. Therefore, we are excited to introduce our new service: FAQ Friday. This week Stefan Menzl answers questions about responsibilities of Economic Operators.
May 15, 2020

FAQ Friday: Answers to your questions about the effects of the MDR postponement on MDD certificate renewal

We know there are a lot of questions regarding new regulations. Therefore, we are excited to introduce our new service: FAQ Friday. This week Robert Paassen answers questions about the effects of the MDR postponement on MDD certificate renewal
May 08, 2020

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

We know there are a lot of questions regarding new regulations. Therefore, we are excited to introduce our new service: FAQ Friday. This week Diana Nogueira answers questions about clinical development plans and strategies
May 01, 2020

FAQ Friday: Answers to your questions about documents that accompany the device

We know there are a lot of questions regarding new regulations. Therefore, we are excited to introduce our new service: FAQ Friday. This week Giovanni di Rienzo answers questions about documents that accompany the device.
April 24, 2020

FAQ Friday: Answers to your questions about Class l Device Safety

We know there are a lot of questions regarding new regulations. Therefore, we are excited to introduce our new service: FAQ Friday. This week Jasmin Hunter answers questions on the subject class l device safety.
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