EU MDR

Summary Most manufacturers have a risk management file. Far fewer have a risk management process that stays current, connects meaningfully to clinical…

Summary Under EU MDR 2017/745 , post-market surveillance is no longer a passive requirement. It is an active, continuous process of collecting,…

How PRISMA Principles Support Transparent and Defensible Medical Device Literature Reviews Literature reviews play an increasingly important role in demonstrating the safety…

Applying PRISMA Principles to Meet MEDDEV 2.7/1 Rev 4 and Annex XIV Requirements Starting an EU MDR literature review can feel overwhelming.…

Mendeley and Reference Management Software: Why They Fall Short for EU MDR Clinical Evaluation Introduction The use of reference management software and…

EU MDR CER Checklist: What to Review Before Submitting Your Clinical Evaluation Report Clinical Evaluation Reports are central to demonstrating the safety…

Why Clinical Evaluation Reports Are Rejected Under EU MDR – and How to Avoid It Introduction Clinical Evaluation Reports (CERs) play a…

EU MDR Consultant Selection: What Matters Most Selecting the right EU MDR consultant is often more challenging than expected. Many manufacturers invest…