Hardware Podcasts

059 - Literature Review, EU MDR CER’s, and Being Problem Driven with Ethan Drower

Let's Combinate · 16 Nov 2022 · 41m

What this episode covers

Ethan Drower, Co-Founder of CiteMed, explains how his company uses software to streamline the literature review process for EU MDR Clinical Evaluation Reports (CERs). He details the shift from ad-hoc searches to rigorous, reproducible protocols required by notified bodies, emphasizing the need to track search results and maintain continuous risk-benefit assessments. Drower discusses the operational challenges of managing large portfolios of devices and the importance of validating software tools to ensure compliance and efficiency in regulatory submissions.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
CiteMed, FDA
Also
EU MDR, Clinical Evaluation Report, MDR, MedDev, PubMed, Eudamed, ISO 13485, How to Get Rich

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