Medical Device Testing

With the new Medical Device Regulation (MDR), the demands placed on manufacturers are increasing. For example, comprehensive technical documentation is required and proof of biological safety (biocompatibility) is a prerequisite for the approval of your medical devices.

For this reason, Niutec develops test strategies in accordance with ISO 10993-12, ISO 10993-15 and ISO 10993-18 with subsequent toxicological evaluation in accordance with ISO 10993-17.

Medical devices come into contact with various process auxiliaries during their manufacturing process. This can result in the development of critical substances that are hazardous to health. These hazardous substances accumulate, for example, in surface structures and blind holes, they adhere as a thin film to product surfaces or penetrate plastic parts.

With the new medical devices regulation (MDR), the demands placed on manufacturers are increasing. With our targeted cleanliness tests, you can provide efficient and meaningful evidence of the cleanliness of your medical devices.