Literature Search for your CER with Ed Drower
As I have performed some Literature Searches and created some CER myself, I know the difficulty and time of doing that. But I also had to audit some CER reports and I am always surprised by the way this is done. With the new Medical Device Regulation EU MDR 2017/745, you will maybe have to update your CERs so this is why I decided to focus on this topic for this episode.
To help you perform your CER if they are based on Literature Search, I asked Ed Drower, Director of Regulatory Affairs at CiteMedical Solution, to come to explain to us the best practices to look for your Literature and how can you check that they are the most relevant for your Clinical Evaluation Report.
In this episode, we will also discuss timing to perform CER and Ed will share with us what Cite Medical Solution can propose to its customers. On the links below, Ed accepted to share some examples on how to create a CER.
In case you need more information on Clinical Evaluation Reports or CER, I propose you to listen again to the Podcast episode made with Helene Quie from Qmed Consulting. This is also one of the most listened episodes.
Who is Ed Drower?
Ed Drower is the Director of Regulatory Affairs at CiteMedical Solutions. In his last 10 years, he has supported filings and reviews of individual medical devices and combination products both in the US and Europe.
With decades of clinical research and drug development experience, Mr. Drower provides a broad perspective to regulatory compliance, document review, and preparation, as well as offering, managed solutions for the upcoming MDR release.
His company CiteMedical Solution is also helping its customers to perform the Literature Search described in this episode so don’t hesitate to contact them.