Post-Market Surveillance Process and What It Will Cost You
Post-market surveillance and vigilance costs are overgrowing. For example, the number of reported adverse reactions [...]
Five Practical Tips For Clinical Literature Review
The European Medical Device Regulation (MDR) outlines the requirements for the literature review needed [...]
Literature Search: How Much Research is Enough?
The research process is often thought of as a linear, straightforward path. You begin with [...]
Literature Reviews Under The In Vitro Diagnostic Regulation (IVDR)
Literature reviews are an essential part of the clinical evaluation process for medical devices. [...]
In Vitro Diagnostic Device Regulation (IVDR)
The In Vitro Diagnostic Regulation has held the center of the medical device manufacturers' community's [...]
Post-Market Surveillance, Market Surveillance, and Vigilance – What is the Difference?
Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when [...]
10 Tips about Feedback from Clients and Users for Medical Device Manufacturers
Feedback is important. No matter what you're selling, if you want to improve, it's [...]
Five Practical Tips for Writing a Compliant Clinical Evaluation Report (CER)
Even for experienced medical writers and regulatory staff, writing a compliant clinical evaluation report [...]