Systematic Literature Review

By |2021-08-31T02:58:41+00:00August 31st, 2021|

In May 2021, the European Medical Device Directive (93/42/EEC) was replaced with the Medical Device Regulation (MDR, 2017/745). Unlike the MDD, the MDR considers clinical evaluation to take place during the full lifecycle of medical devices, meaning clinical data must be updated continuously. Seeing as clinical data is usually sourced from clinical investigations, post-market [...]

How to Hire a Literature Search (or CER) Writer and What to Look For?

By |2021-07-11T17:00:08+00:00January 27th, 2021|

INTRODUCTION A literature search is a deliberate and efficient search from already distributed information to distinguish between a good quality reference on a particular topic. There are different reasons for conducting a literature search, including drawing information for making evidence-based reports, academic assessment, and a step in the research methods. A thorough literature search [...]

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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