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 FDA, MDR, 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. 

• Biocompatibility 
• Chemical/physical analysis 
• Class I,II, III medical devices
• Combination products
• Container closure integrity testing 
• Ethylene oxide sterilization
• Human factors testing
• Microbiology & sterility testing 
• Ophthalmic testing 
• Package testing 
• Shelf life and aging studies
• Toxicological risk assessment

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