Placing your sterile medical device on the market

A sterile medical device is a device that must be free from viable bacteria or other microorganisms and their spores. Sterile medical device requirements are defined by national or regional standards and regulations, which detail the level of sterility assurance. Sterilization of a medical device may include exposure to ethylene oxide, gamma irradiation, steam, dry heat, or chemical sterilization under defined conditions, and any necessary post-treatment required for the removal of by-products.

The process of CE or UKCA marking for sterile medical devices can be challenging. The implementation of the appropriate sterilization technique is essential for the successful outcome of your application.

Microbiology audit is essential to reduce patient risk and is an integral part of sterile medical devices assessment.

Microbiology audit and assessment include:

• Verification on the efficacy of controls in place for pre-sterilization bioburden, microbiological cleanliness and controls to assure your medical device sterility
• Assessment of environmental monitoring and controlled environment
• Verification of effective implementation of sterility assurance levels through sterilization and sterile barrier validations
• Assessment of suitability and effectiveness of disinfectants and sterilizers
• Assessment of suitability and effectiveness of instructions for end user cleaning, disinfection, sterilization and reprocessing.
• Assessment of product endotoxin testing including source.
• Verification of Sterile Release processes for all modalities.

Along with microbiology assessments, we provide certification services for Medical Devices Single Audit Program (MDSAP) and ISO 9001. We also provide ISO 13485 certification for provision of sterilization activities as per EN ISO 11135 and EN ISO 11137-1. We also conduct Technical Documentation reviews under the IVDR, MDR and UK MDR 2002.