Approval & Regulatory Affairs
The pathway to approval for your medical device
In the “Approval & Regulatory Affairs” section, we provide an overview of the legal framework for the approval of medical devices and give strategic advice.
In order to launch a medical device on the German healthcare market, precise and error-free planning of the strategy for approval is crucial. It goes without saying that all legal requirements must be observed and complied with. We provide you with an overview of all regulations and information on how to achieve regulatory compliance for your product.
Particular emphasis is placed on the successful CE approval of medical devices through implementation of the Medical Device Regulation (MDR), on the required conformity assessment procedures and the clinical evaluation of medical devices, and on the inclusion of digital health applications (DiGA) in the DiGA directory of the Federal Institute for Drugs and Medical Devices (BfArM). We will also discuss the topic of post-market surveillance.
- Practice-oriented and effective learning
- Up-to-date and sustainable know-how transfer
- Flexible e-learning
- High level of expertise in the healthcare sector
- Many years of experience
- A unique network
- Customized support and one on one-coaching
- One stop shop
Register now and ensure successful market access