Design controls

We guide you through every stage of the product lifecycle, aligning with standards like ISO 13485 and 21 CFR Part 820.

From concept through design validation, we provide comprehensive support for Verification & Validation (V&V). Our services include developing tailored project plans, creating robust protocols, executing studies, and delivering clear, compliant reports aligned with the most recent standards relevant to your medical device. This ensures regulatory readiness and a smooth path to premarket submission.

The project plan considers Risk Management alongside V&V. Our project plan integrates Risk Management with Verification & Validation (V&V) to ensure patient safety and regulatory compliance. V&V activities cover all design controls required to demonstrate that your medical device is safe and effective for its intended use.

Eurofins Medical Device Consulting is your partner in addressing potential regulatory concerns in V&V. Leveraging design review and transfer expertise, our consultants can establish new design plans.

We establish the risk management process for you aligned with ISO 14971:2019 requirements, including risk management plan, risk analysis and risk management report including benefit risk analysis.

If the services of an external laboratory are needed, our experts can help you to find a trusted testing partner that suits your needs and to develop a testing plan and/or protocol, including sterilization validation and batch release, biocompatibility, transportation, shelf life, packaging and sealing validation, cleaning validation and reprocessing, and more.

Our experts establish a complete Design History File (DHF) and can guide you through the design transfer process in-house or by contracting a manufacturer.