[FREE WEBINAR] Stay Focused: The Purpose of the SVR and Tips for Building a Strong PER Foundation
Click here to watch the recording of this webinar. The goal of performance evaluation is to show that your IVD performs as intended and meets the acceptance criteria, therefore establishing […]
[FREE WEBINAR] Plain Language Communication in Healthcare Part 1 Webinar
Click here to watch the recording of this webinar. Medical device manufacturers and pharma/biotech companies have a regulatory and legal obligation to convert key scientific content into plain language for […]
MDCG 2022-12: “Alternative Solutions” Document. Interim Guidance for IVD Manufacturers
Author: Criterion Edge Writers What You Need to Know The Medical Device Coordination Group (MDCG) released a new document (MDCG 2022-12) to establish guidelines for in vitro diagnostic medical device […]