Whitepapers

UKCA Mark – where is it going and what should you do now?

Whether it is ‘domestic’ or ‘global’ Britain, the reality is the same – the sector faces huge upheaval again. The creation of a new regulatory framework offers opportunities but raises concern around duplication and additional burden.
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A Guide of Clinical Investigation with Medical Devices in Europe: Pre- and Post-market requirements

This whitepaper summarizes the different types of clinical investigations in the EU as per MDR 2017/745, the submission routes and submission documents, and also on reporting requirements during conduct, and after completion of a clinical investigation.
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Germany SAE Reporting for Clinical Investigations as per MDR 2017/745 Articles 62 and 74.2

This paper provides you with an overview of SAE reporting requirements for clinical investigations with Medical Devices as per MDR 2017/745 Articles 62 and 74.2 in Germany, supporting you to report in a timely and correct manner.

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Vigilance reporting Requirements MDR 2017/745, MPDG and MPAMIV in Germany

This whitepaper summarizes the overview of Vigilance reporting requirements  per MDR 2017/745, MPDG and MPAMIV in Germany
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