ISO 10993
Biological safety evaluation for medical devices
In order to evaluate the biocompatibility of your medical device, qualitative and quantitative data must be collected on the materials that make up the devices in the context of biological safety. The biological safety evaluation for medical devices is a regulatory safety requirement that ensures that a device is compatible with the human body as per its intended purpose.
According to ISO 10993 family of standards, a majority of medical devices need to undergo biocompatibility testing.
Biological safety evaluation services we offer:
Determine
Determine together with you the right evaluation and testing strategy for your Class I medical devices up to Class III (absorbable) implants.Select
Select and arrange suitable testing laboratories to carry out your biological safety tests.
Implement
Implement or update your biological risk management process.
Perform
Perform your toxicological risk assessment.Update
Update or prepare your biological safety evaluation plans and reports in accordance with the requirements of the ISO 10993 standards and the Medical Devices Regulation.Support
Support with international requirements for biological safety evaluation for medical devices.
Ready to take the next steps?
If you are a medical device manufacturer looking for support for your biological safety evaluation, Qserve Group is your partner. We can help ensure regulatory compliance, identify potential areas for improvement, and maintain the highest level of product quality.
Schedule a free introductory call