Important Documents


In general, certification authorities examine extensive written applications. The data contained in these documents are intended to demonstrate that the product or process submitted for approval complies with the so-called Essential Requirements for Medical Device. Together with you and on your behalf, we will develop the complete content of such an application. In addition, we also ensure that the correct form of the documents is maintained, as this is as important as the data they contain for the success of the audit.

Essential Requirements for Medical Device

 

Safety

Risk Classification

Risk Management

Quality Managament

Technical Performance

Product file including declaration of conformity, description, specification, verification, validation

Clinical

Performance

Evaluates suitability for the intended purpose based on clinical data