Regulatory compliance is essential in medical device manufacturing, but navigating the technical documentation needed to support it can be complex, time-consuming, and overwhelming. Whether you're compiling a Design History File, preparing a technical file for submission, or identifying gaps in existing documentation, challenges exist around lack of internal resources, evolving regulatory expectations, and delayed approvals.

Eurofins Medical device Consulting understands the critical role that well-structured, compliant documentation plays in the success of your device. Our global experts provide precise, end-to-end support by managing documentation across the product lifecycle, from development and pre-submission planning to post-market updates. We help you interpret requirements, close documentation gaps, and ensure every element of your submission aligns with the expectations of regulatory authorities.

After CE marking or FDA approval, we can also maintain this technical documentation for you. This includes change assessment documentation updates, technical file and Design History File maintenance, as well as communication with authorised representatives and regulatory authorities (e.g. FDA).