Biological Evaluation of Medical Devices

For the biological evaluation of a medical device, a step-by-step evaluation should be carried out according to EN ISO 10993-1.

Step 1: Chemical and Physical Evaluation: In this step, the entire content of the product should be revealed.

Step 2: Chemical Characterization: Undetected and unidentified content should be revealed by tests.

Step 3: Risk Assessment: All identified ingredients should be evaluated for whether they pose a biological risk.

Step 4: Biological Tests: If there is data that cannot be fully evaluated, product safety should be supported by biological tests. If these steps are not followed in order, an accurate safety assessment cannot be made for the medical device.

We evaluate the product for each step and follow your process step by step. In cooperation with laboratories, we guide the pre-clinical evaluations of your product and finalize your process with a scientific point of view.