MEDDEV 2.7.1 Rev 4 Clinical Evaluation A Guide for Manufacturers and Notified Bodies, released and effective from June 2016, is posing a difficulty for many medical device manufacturers. It requires a vastly different approach from the previous revision of the guidance in the generation and approval of the Clinical Evaluation Report.
We have written many CERs, which have been reviewed and accepted by many Notified Bodies and regulatory agencies outside Europe. We can assist you in yours also.
Regulatory Affairs ›
Considering the global regulatory impact of operational and business decisions on the business is key to the success of the business ...Read more ›
Design Assurance ›
The product development process is a structured approach, which if adhered to, can have significant influence on a smooth regulatory approval process ...Read more ›
Clinical Affairs ›
Depending on the novelty, intended use and risk level of your medical device, you may need to perform a clinical investigation ...Read more ›