At PRETOX CONSULTANCY (PTC), we provide expert guidance for medical device biocompatibility to and safety testing, ensuring full compliance with ISO 10993 and global regulatory requirements. Our goal is to help manufacturers assess, design, and validate safe, effective medical devices through scientifically sound testing strategies.

We support both in vitro and in vivo testing programs, helping clients identify potential biological risks and implement the most appropriate evaluation pathway.

Medical device- biocompatibility testing:

Safety evaluation of a product based on its composition, materials, and intended uses:

• Chemical Characterization of Materials – ISO 10993-18
• Hemocompatibility – ISO 10993-4
• Irritation – ISO 10993-10
• Sensitization – ISO 10993-10
• Genotoxicity (Bacterial Reverse Mutation, Micronucleus test, Chromosomal Aberration test) – ISO 10993-3
• Cytotoxicity test – ISO 10993-5
• Systemic Toxicity and Pyrogenicity – ISO 10993-11
• Implantation test by various routes – ISO 10993-6

TOXICOLOGICAL RISK ASSESSMENT FOR MEDICAL DEVICE

• Extractables & Leachables (E&L) analysis respect to allowable/acceptable limit for medical devices according to ISO 10993-17: Biological Evaluation of Medical Devices