Regulatory support

From the design to the marketing of medical devices, the CTTM is the preferred service provider to help you enrich your technical file to meet CE marking essential requirements.

• Risk analysis according to the ISO 14971 standard recommendations (Application of risk management to medical devices)
• Physicochemical analysis : analytical reports
• Bibliography studies (articles, directives, harmonized standards, etc.)
• R&D studies and biomaterials screening
• In vitro tests according to ISO 10993 standards
• Bioburden analysis 
• Work in cleanrooms