The continuous changes and amendments made to the rules and regulations for approving medical devices demand highest attention and constant updating of one's knowledge level. For remaining competitive in the market, manufacturers need to be equipped with profound knowledge of all applicable rules and standards and apply them appropriately and traceably.
Medical device approval is complex.
The range of services and knowledge built around the topic "Regulatory Affairs" is broad and bears on numerous different directives, laws, regulations and standards. At the same time the internationalisation results in a diversity of country-specific regulations with clear differences.
The core issues of this area are amendments made to products, labelling of the same, and tests prior to market introduction. Establishing and maintaining technical documentation that complies with the Medical Device Regulation (MDR), additional CE Directices, if applicable, and also fulfills the slight differences relevant for international approvals. At this both the requirements of the US Food and Drug Administration (FDA) and the Medical Device Single Audit Programs (MDSAP) occupy a special place.