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augustus 12, 2020

Interview with Michael Yan, Regulatory Affairs Expert

We would like to get you all acquainted with our Regulatory Affairs Expert. An interview where we talk about his expertise, how a normal workday looks like and which trends he observes in the MedTech-world. Ending the interview with valuable advice for everyone in the MedTech world!
augustus 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.
augustus 04, 2020

MDCG Guidance 2020-12

Transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using transmissible spongiform encephalopathy (TSE) susceptible animal tissues.
juli 31, 2020

FAQ Friday: Answers to your questions about US agent

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, Max van Regteren answers multiple questions about US agent.
juli 29, 2020

Why Overall Accuracy Isn't Sufficient? 

There are many changes impacting the IVD world at present, changes to regulation such as the impending implementation of the IVD Regulation in Europe and also new disease states such as SARS-Cov-2 that have been impacting all our lives. 
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