From experience gained from multiple product dossiers, we thoroughly understand the European regulatory framework for active medical devices (MDD/MDR), the obligations set out for all key players in the device’s life cycle, and the challenges many parties face.
For non-medical devices (e.g. laboratory equipment), we give advice on the directives and regulations that are applicable to your product. We can conduct a search for consensus standards that allow you the benefit of presumption of conformity with the directive’s requirements. Based on our experience from marketed active devices, we offer advice on the least burdensome approach in building up your technical documentation, to comply with the applicable directives and pass regulator’s controls if they take place. We provide recommendations on the documents to take to the accredited test laboratory for testing required for certification, and on smart ways to reach markets outside European Union.
If something is unclear to you or if you are just looking for a second opinion, Unitron Regulatory offers advice on topics like:
➜ applicable regulations, directives and standards
➜ information and documents required for submissions
➜ quality management system procedures
➜ technical file management
➜ medical device classification and conformity assessment routes
➜ risk management
➜ software classification and development
We can also give presentations on regulatory subjects for e.g. your board, development team or conference.