In this whitepaper, we will define what is meant by current knowledge/state of the art in the context of the clinical evaluation, and will provide an overview of requirements and best practices that are MDR compliant, detailed in the MEDDEV 2.7/1 rev 4 guidance.
Download our white paper to learn the answers the these questions...
There’s no substitute for experience. Not just writing experience, but industry experience – collectively, the CE team represents over 4 decades of direct industry experience. The team is among the best in the business. Top-flight, advanced-degree clinical professionals with years of experience writing an array of regulatory reports for medical device manufacturers and pharmaceutical and biologics companies.
To learn more about how Criterion Edge can help you achieve your regulatory goals, see criterionedge.com, or contact the company at info@criterionedge.com or, by phone, at +1-805-202-5520
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