This gap analysis defined in MEDDEV 2.7/1 revision 4, CE is a “procedure to collect, appraise and analyze clinical data pertaining to a medical device and to evaluate whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer’s Instructions for Use.”
In a series of gap analyses, Criterion Edge will select critical changes from these guidelines and examine them.
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.