You know what your device is capable of delivering, but the big challenge lies in proving it within regulatory frameworks. Ensuring your medical device is safe, effective, and fit for its intended use requires implementation of comprehensive design controls early and effectively. It means managing Verification and Validation without delays, addressing risk at every phase, and preparing for submission with confidence.

Eurofins Medical Device Consulting supports you from concept through to design transfer. Our experts will work closely with your teams to implement, manage, and document every aspect of the design control process, in full alignment with FDA 21 CFR 820 and EU MDR expectations.

Whether you're developing a Class I, Class[GS1]  II, or Class III device, we can help you navigate:

• Project Planning and Risk Management: We support you in building structured development plans, including robust risk management strategies aligned to ISO 14971.
• Verification and Validation (V&V): We manage V&V activities across the entire lifecycle, ensuring compliance and technical accuracy from protocol creation to report delivery.
• Test Protocol Development: Our teams write protocols, and compile documentation tailored for regulatory review.
• Design Review and Transfer: If a V&V phase identifies issues, we assist with corrective planning, revalidation, and updated documentation to support seamless design transfer.
• Design History File (DHF): We compile and maintain the complete DHF, ensuring every design decision is traceable and defensible.

Within Eurofins Medical Device Services, you access a global network of laboratories with proven experience in testing medical devices and a clear understanding of regulatory protocols. By guaranteeing you a clear view of next steps, regulatory needs, and project risks, our collaborative approach will reduce rework, avoid unnecessary costs, and accelerate time to market.