How to Hire a Literature Search Writer and What to Look For

By |2021-03-18T02:34:37+00:00January 27th, 2021|

How to Hire an EU MDR Literature Search (or CER) Writer and What to Look For With the upcoming transition to the EU MDR ( Medical Device Regulation (MDR) 2017/745) in May 2021, medical device manufacturers are facing constant monitoring and life-cycle management of their clinical data. In the European Union, the Clinical Evaluation Report (CER) is critical [...]

Periodic Safety Update Reports: Why You Might Need One Annually

By |2021-03-03T21:40:36+00:00July 25th, 2019|

Periodic Safety Update Reports:  Why You Might Need One Did you know that the Literature Searches you submit for your CE Marking Clinical Evaluation Report might have to be re-run annually? Most that have already submitted an MDR compliant CE Marking Dossier for their products are aware of the need [...]

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