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八月 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.
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七月 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.
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七月 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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七月 29, 2020

The new ISO14155 standard for Good Clinical Practice is now published!

After many delays it now officially available: the new ISO14155 standard for clinical investigations of medical devices for human subjects — Good clinical practice . This third edition of the standard cancels and replaces the second edition from 2011. 
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七月 29, 2020

Interview with Adriana Becker, US Regulatory Affairs Expert

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