Bringing a new medical device to market is a feat of innovation—but also one of navigation. Regulatory frameworks are stringent, constantly changing, and demand a quality management system (QMS) that is as rigorous and reliable as the product it supports. For manufacturers, the challenge lies not only in implementing a QMS that meets ISO 13485 and 21 CFR Part 820 standards, but also in maintaining and adapting that system across the full lifecycle of the device—from concept through production, post-market surveillance, and beyond.

With deep regulatory understanding, decades of experience, and a highly qualified team of QMS specialists, Eurofins Medical Device Consulting supports medical device companies in designing, building, and maintaining fully compliant, inspection-ready quality systems. We assist you with writing policies and procedures, preparation and implementation of the Quality Manual, implementation of Standard Operating Procedures (SOP) and quality processes, as well as internal audits and supplier qualification.

As your product evolves, so must your QMS. That’s why our consultants stay engaged, helping you update and maintain documentation following design or manufacturing changes according to ISO 13485 and 21 CFR part 820. Our experts are proactive, pragmatic, and trusted by regulatory bodies worldwide.