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MedDev 2.7/1 Guideline: Evaluators Qualification and Scientific Validity

This gap analysis will address key revisions to the topics of evaluator qualifications and scientific validity in the Clinical Evaluation (CE) MEDDEV guideline. The objectives of this report are for manufacturers and stakeholders to understand what the revisions are and to plan for how to comply with them.

The Criterion Edge Team

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, or contact the company at or, by phone, at +1-805-202-5520

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