Especially new innovative companies, i.e. start-ups, are confronted with many regulatory hurdles for the first time. However, these should not put a brake on the drive. We, the Medical Device Consultants of BEO BERLIN, provide orientation and practical information on the topic of “ EU-Medical Devices Regulation (MDR) and requirements for start-ups“. The experts at BEO BERLIN help where help is needed and thus create space for your core competencies.
Based on their expertise, BEO BERLIN advises when is the right time to start creating CE documentation and when is the right time to start testing, which should be done first and which last.
- What do you do yourself and what do you outsource?
- What else needs to be considered besides the MDR and what comes after CE certification?
We answer frequently asked questions and discuss with you the pros and cons of the many options you have as a start-up.
BEO BERLIN is a permanent and reliable player in the medical device industry. Meeting the requirements for medical devices according to MDR and for medical aids according to Book V of the Social Code (SGB V) is our daily bread.
