We work with manufacturers of medical devices to provide and manage specialised microbiological, sterilisation and packaging testing, helping to ensure that you have effective processes and controls in place to verify and validate the sterility of your medical device.
We can help you with the following standards:
- BS EN ISO 11135 – 1 (Sterilisation of health care products)
- BS EN ISO 11737 – 1 to 3 (Sterilisation of medical devices – microbiological methods)
- BS EN ISO 11137 – 1 (Sterilisation of healthcare products)
TRaC can manage the entire verification and validation process for you, defining appropriate and controlled manufacturing processes including those for the use of clean rooms or controlled environments.
In addition we can validate:
- The suitability and effectiveness of instructions for end-user sterilisation
- The suitability and effectiveness of disinfectants
- The effectiveness of sterilisers
To learn more about how our medical device microbiological testing can add value to the design and testing of your medical devices, email your specification and requirements to firstname.lastname@example.org, enter your details into the blue form or call us on the number in the top right hand corner of this page.