The field of regulatory affairs "Regulatory Affairs" deals with everything concerning legal or normative requirements for placing medical devices on the market. From dealing with harmonized standards, to conformity assessment and post-market surveillance, RA experts are the point of contact for the requirements placed on these processes and activities by the relevant regulations for economic operators.
In Europe, these requirements are described in the MDR and IVDR, respectively.
The following pages describe how a device can be put on a wide variety of different markets worldwide. Often, a simple registration or confirmation of approval in the home market is sufficient. However, it can also be complicated; for example in China, the hurdles are particularly high. Additionally, in many African countries, a local contact is essential.
We will help you keep track of the different approval restrictions. Our experts know how to bring your product to market - whether in Europe, Asia or America.
- Which clinical strategy do I use to evaluate my software as a medical device according to MDCG 2020-1? We know the regulatory requirements.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 31/22
- Life Cycle management tool support in medical technology. DOORS, RQM or ELM - correctly manage requirements, tests, documentation and traceability.
- Areas: Europe, Worldwide / Updates, New regulations and guidances 20/22