ABOUT US

CertMed is a specialized provider of third-party regulatory testing, validation, and certification services for medical device manufacturers. We support clients across the full product development lifecycle—offering technical expertise and regulatory alignment to accelerate market readiness and ensure sustained compliance.

Our service portfolio includes:

• Biocompatibility testing and toxicological risk assessments in accordance with ISO 10993 series
   
• Cleaning, disinfection, and sterilization validation for reusable medical devices (ISO 17664, AAMI TIR30, FDA guidance)
   
• Usability engineering and human factors validation aligned with IEC 62366 and FDA expectations
   
• Cybersecurity risk assessments and software validation per IEC 62304, IEC 81001-5-1, NIST, UL 2900, and MDR Annex I
   
• Electrical, mechanical, microbiological, chemical, and packaging performance testing
   
• Regulatory documentation support for CE marking, FDA 510(k), and global market submissions
   

Our testing services are conducted within an ISO 17025-compliant quality management system, with select studies available under GLP compliance for regulatory submissions. We also assist with gap assessments, remediation strategies, and validation protocol development tailored to complex or high-risk device categories—including active, AI-enabled, and software-driven products.

With a multidisciplinary team and up-to-date knowledge of evolving global requirements, CertMed is your trusted technical partner in delivering safe, effective, and fully compliant medical technologies.