• Regulatory Affairs
• Sterilization & Microbiology
• European Authorized Representative

Sterilization and Microbiology

Sterilization and Microbiology for Medical Devices

We can assist and advise as expert from development of the sterilization process to the release of the sterilized products, as needed:

• Selection of sterilization method:
• Ethylene Oxide - ISO 11135
• Irradiation (gamma, e-beam and X-ray) - ISO 11137-series
• Moist heat/Steam - ISO 17665

• Validation of sterilization - create and review protocols and reports

• Validation and routine determination of microbiological tests:
• Bioburden - ISO 11737-1
• Sterility - ISO 11737-2
• Bacterial Endotoxin - ISO 11737-3

• Create and review Quality Procedures for sterilization and microbiology

• Assist in submissions to notified bodies and regulatory authorities

• Supplier audits