Your business plan failed due to wrong product approval? Not with us! Our experts support you with training, as external resources in projects or even as the "person responsible for regulatory compliance" (PRRC) in day-to-day business, from approval strategy to effective market surveillance:
Are you looking for alternatives to the costly initial approval in Europe under the MDR?
We support you in clarifying relevant regulatory issues on the way to a sound regulatory strategy:
Our experts provide support from the preparation of the required approval documents to the successful registration of your product in various markets (EU, US, CAN, CN, etc.):
Systematic market surveillance is a key instrument under the MDR and involves considerable effort. However, if implemented appropriately, market surveillance can also contribute to a better understanding of the products on the market. We support you, from the development of effective processes to the assumption of monitoring and reporting activities:
As part of our activities, we continuously monitor the regulatory requirements of various markets and ensure that our experts remain up-to-date. We are happy to share our regulatory knowledge with you and support you with the following services: