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 part 1 of this series which assesses common gaps and suggestions to bridge those gaps in the state of the art (SOA), Safety and Performance (S&P), Equivalence, and Systematic Literature Review (SLR) sections.
Learn the purpose, methodology, and organization of the state of the art, safety and performance criteria, equivalence, and systematic literature review sections. You'll also receive examples of common observations/gaps in each section. Use our task list as part of your CER gap analysis to generate a CER that is MDR-compliant, and answer critical questions prior to submission.
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.
To learn more about how Criterion Edge can help you achieve your regulatory goals, see criterionedge.com, or contact the company at firstname.lastname@example.org or, by phone, at +1-805-202-5520