Developing safe, effective, and compliant medical devices has never been more complex. You’re expected to maintain accuracy, patient safety, and performance, while managing risk, budgets, and tight timelines. What you need is a validation partner who understands the full scope.
Eurofins Medical Device Consulting offers global expertise in validation across all core disciplines: cleaning, packaging, cleanroom, reprocessing, and computer system validation (CSV). Our teams of highly trained scientists and consultants support you from planning through execution, ensuring your processes are robust, regulatory-compliant, and audit-ready. No matter the product type or development stage, we ensure your validation journey is efficient, future-proof, and fully compliant.
Contaminants such as microbiological residues, detergents, and processing residues can compromise product safety. Eurofins Medical Device Consulting helps validate your cleaning procedures using internationally recognised standards including ISO 19227, ASTM F3127, and DIN/TS 5343. We tailor test designs to your device and process, selecting appropriate methods like TOC, bioburden, and bacterial endotoxins, and helping you navigate any unexpected results.
To meet global requirements like FDA 21 CFR Part 820, EU GMP Annex 1 (2022), the ISO 14644 series, and User Requirement Specifications (URS).we guide you through full cleanroom validation lifecycles—from Design Qualification to Performance Qualification—plus revalidation (when required) and Cleanroom Certification & MonitoringOur support ensures process integrity and controlled environments throughout manufacturing.
CSV ensures your systems align with GAMP 5, FDA 21 CFR Part 11, and EU (Annex 11, EudraLex Volume 4). We offer complete CSV strategies, from regulatory gap analysis and protocol development to test execution and continuous improvement, ensuring secure, accurate, and compliant digital processes.
Sterility and integrity are paramount. We support packaging validation to ISO 11607 standards, including testing barrier systems, simulating transport conditions, and defining shelf-life strategies—ensuring the device arrives sterile, intact, and safe for use.
Reusable medical devices demand meticulous reprocessing and risk management. We help define procedures, conduct risk analysis, and generate custom testing strategies—optimised for cost and time. Training can also be provided to keep your teams aligned with the latest global regulatory updates.