Biological evaluation is a vital part of the validation process when developing new medical devices. It is also required for existing medical devices which have undergone a material change and may have contact with a patient.
The biological evaluation report will demonstrate that a medical device will not cause potential biological risks. All biological evaluations must conform to the requirements of ISO 10993.
The biological evaluation report should be carried out by suitably qualified persons. Here at Patient Guard, our medical device consultants have the correct qualifications and experience required to guide you through the entire process. We have also partnered with testing houses that can perform any required medical device testing.
If you need support with the biological evaluation report of your device, then please contact us for further information.