Link to episode on Apple Podcasts
In this episode, the Frestedt Incorporated team discusses their recent experience with writing 14 Clinical Evaluation Reports (CERs), including the purpose and scope of these reports and some tips to address common pitfalls they observed during CER writing.
Links to resources in this episode:
Med Dev 2.7.1
EN ISO 14971:2012 (link to purchase; not available for free online)
PubMed literature database
FDA 510(k) database
FDA TPLC database
FDA Recalls database
FDA MAUDE database
ClinicalTrials.gov website
Episode 2 : Infusing Risk-Benefit Analysis into Clinical Evaluation Reports