Risk & quality management in the context of MDR
31 March 2020
Especially under the new MDR, it is becoming increasingly important to know all the specifics of medical device approval. As experts, we support you in meeting regulatory requirements and in the all-important risk and quality management.
Risk & quality management
Are you unsure on how the MDR impacts your quality and risk management? We are here to help you!
- Risk management support
- Quality management system implementation
- Liaison with Notified Bodies and Competent Authorities
Medical & regulatory affairs
Are you in need of writing a clinical evaluation and/or any other scientific document? We have the solution – tailormade exactly for your needs!
- Medical marketing
- Post-market surveillance plan
- EUDAMED reporting
Are you up to date with the Medical Device Regulation and clinical research? We are experts and very happy to share our knowledge with you and your organization!
- Face-to-face and online training
- Established clinical research curriculum
- Hands-on expertise
Let us know what challenges you are currently facing, we are happy to assist you in finding the right solution for you.
Further quality assurance