Demonstrate the safety of your medical device to obtain a CE certification.

Medical devices, whether for diagnosis or treatment, often are in direct contact with living tissue, in cases like implants over long period of time. And even with indirect contact only, devices have to be designed to guarantee they don’t have any negative impact on the human body. Manufacturers therefore are required to perform a biological evaluation of their product before placing it on the market.

THE FORCE supports you in demonstrating your compliance with the general safety and performance requirements (GSPRs) as laid out in Annex I of the MDR or the IVDR, respectively.

When it comes to safety, our experts on the development of medical devices and toxicology take chemical, physical, and biological properties of the device into account by paying particular attention to:

the choice and compatibility of raw materials and substances used;
the impact of the manufacturing, transport, and storage processes as well as the application of the device; and
the mechanical properties and interactions of the different parts of a medical device.

Our team follows the standards on the various aspects of biocompatibility addressed in the ISO 10993 framework, beginning with ISO 10993-1 for biological evaluation and testing in a risk-based approach in line with ISO 14971.

Combined with our experience, we provide the best possible approach to evaluate the biological safety of your medical device, placing special emphasis on:

substances which are carcinogenic, mutagenic, or toxic to reproduction;
endocrine-disrupting substances;
infectious and microbial contamination; and
devices containing derivatives of tissues with animal or human origin.

This way, we’re able to determine measures needed to ensure the highest possible level of safety and performance of your medical device.

Reach out

to demonstrate the safety of your medical device.