What\u2019s involved in a systematic literature review for the EU MDR, and how should companies handle those steps? In today\u2019s episode, you\u2019ll hear from Co-Founder and Operating Partner of CiteMed, Ethan Drower, on the topic of Systematic Literature Reviews for EU MDR Clinical Evaluation Reporting.
In today\u2019s conversation, we covered topics like where information for the literature review comes from, the types of tools used to make evaluations, and more. Listen to the episode to hear what Ethan has to say about the process of performing a CER, the mistakes and pitfalls he sees people make in the process, and what kinds of actionable steps companies can take.
\u201cIn comparison to the FDA, the big change, the big difference that\u2019s happened with EUMDR is kind of a renewed scrutiny and focus on your actual data.\u201d
\u201cIt\u2019s a compilation game, which is why nobody likes doing it. Because you have to bring in so many different pieces of data and different plans and that\u2019s why it\u2019s a difficult document to write.\u201d
\u201cOnce you\u2019ve gone through the nightmare of pulling all this information together, now somebody has to read it.\u201d
\u201cDon\u2019t expect that what you searched and your process in the past, don\u2019t expect it to just work and be glossed right over. It needs to be exceptionally thorough, and it needs to be iron tight.\u201d