This white paper is a companion piece to our popular webinar where we present strategies for assessing key components of your clinical evaluation report (CER or CER template) for possible misalignment with significant and applicable MDR requirements. Download the second part of this series which details common observations and gaps among clinical data sources, the risk-benefit analysis, and overall analyses and conclusions.
Criterion Edge is a focused service provider, delivering medical/regulatory writing and clinical safety services to the pharmaceutical and medical device industries. The company’s expertise in regulatory writing and safety, honed over decades, utilizes best practice processes, produces superior deliverables, and provides budget, resource and timeline flexibility for clients. Criterion Edge empowers companies to deliver superior health care solutions.