We create documentation for new medical devices or update existing documentation to the current versions of MDR 2017/745 and IVDR 2017/746. The performance requirements for technical documentation in relation to the MDR/IVDR have increased significantly, both with regards to content and with regards to scope. This means that substantially more depth of content is required, and the field of post market surveillance (PMS) must also be considered, according to the current amendments. Clinical assessments and clinical trials are so strongly regulated that a purely theoretical view is almost impossible.
What has changed and what exactly does this mean for your product and company? Our compliance engineers are well-versed in the topic and use their professional expertise to create professional documentation, tailor-made for individual requirements.