Integrated Testing & Specialized Consulting

Accelerate medical device milestones with expert regulatory guidance, lifecycle insights, and comprehensive testing solutions. Eurofins Medical Device Consulting will guide you through complexity with confidence.

Consulting

Regulatory strategy & market access – Clear guidance to help you move efficiently through MDR, FDA, and global pathways.
Risk, usability & gap assessments – Identify vulnerabilities early and strengthen your device’s safety profile.
Design validation & V&V support – Build strong, defensible evidence packages for confident submission.
Technical documentation & QMS guidance – Ensure your files and quality systems meet expectations from design through postmarket.
Preclinical biological & chemical safety strategy – Align biocompatibility, toxicology, and chemical characterization with regulatory expectations.
Clinical evaluation planning & reporting – Develop strategic, wellstructured CEPs and CERs that clearly present your clinical evidence.
Postmarket QA/RA lifecycle support – Maintain compliance, support audits, and manage ongoing regulatory requirements

Expert Testing

Navigating the medical device regulatory landscape is complex, especially when safety, compliance, and speed to market are on the line. Knowing what will be tested, how long it will take, and just what the regulatory requirements are for each type of device demands special expertise. Whether you’re developing a Class I, Class II, or Class III device, test strategies must be robust, precise, and aligned with global standards.

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