Get Your Copy

Select All that Apply

Select All that Apply

MedDev 2.7/1 Guideline: More Clinical Evaluations?

This report will focus on critical modifications in the areas of clinical evaluation (CE) updates and post-market surveillance (PMS) from the revised CE MEDDEV guideline. The objectives of this report are to explain the modifications and create a plan for compliance to them. General-ly, these changes suggest the need to submit more CE reports (CERs) to the regulatory authorities, however, strategies will be discussed for managing the increased requirements.

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

Download The free eBook