To support your achievement of the necessary standards – outlined under ISO 13485:2016 – and to keep patients safe, BSI offers a team of qualified and experienced industry microbiologists allowing you to navigate the areas of compliance within the areas of sterilization, packaging and microbiological testing.
ISO 13485 is supported by standards covering specific requirements, including:
- The use of appropriate controlled manufacturing processes that establish a consistent product bio-burden prior to the sterilization process (e.g., use of clean rooms and/or controlled environments)
- Validation and control of the primary packaging process to assure the integrity of the sterile pack
- The validation and control of the sterilization process
Compliance with issues like those outlined above is dependent on effective quality system assessments. We carry out quality system assessments to ensure compliance with the standards of ISO 13485, as well as other global regulations (e.g. Medical Devices Directives, MDSAP, Japanese PMD Act, and sterilization standards). We also perform technical documentation reviews and conduct assessments and reviews of disinfectants under the Medical Devices Directive.