Hardware Podcasts

Systematic Literature Review for EU MDR

Global Medical Device Podcast · 5 Apr 2023 · 38m · Episode 313

What this episode covers

Ethan Drower, Co-Founder and Operating Partner of CiteMed, explains the rigorous process of conducting systematic literature reviews for EU MDR Clinical Evaluation Reporting (CERs). He details how the EU MDR has shifted scrutiny from equivalence to empirical data, requiring manufacturers to search multiple databases like PubMed and Embase to prove device safety. Drower highlights common pitfalls, such as starting too late and failing to maintain continuous post-market surveillance, while advocating for software tools to manage the volume of clinical data.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
CiteMed, Greenlight Guru
Also
PubMed, Embase, Cochrane Library, clinicaltrials.gov, EU MDR, FDA

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