The Johner Institute helps you fulfill your legal obligation: to prove that your products are biocompatible and compliant with the relevant regulatory requirements.
If you wish, we will take care of all organization for all tests Very quick laboratory implementation, inexpensive and without animal testing.
Thanks to material characterization, the verifications have maximum informative value. They not only create a high level of product safety, but also form an ideal starting point for design changes and approvals for other similar products
The path from development to market readiness is a long one. We walk this path together with you and support you in all phases of development, production and market observation:
Faced with the question of whether it is better to outsource your biocompatibility activities or to develop your own structures and knowledge? Together with you, we will find the best approach for you
a) Would you like to outsource the biocompatibility?
b) Would you like to update or develop your know-how?
We tailor everything individually to your specific product and your company.
One of the key elements for biocompatibility is choosing the right testing laboratory.
We have many years of experience in leading testing laboratories for ISO 10993 and have carried out thousands of tests ourselves. We therefore have precise knowledge of the technical requirements for the tests that are necessary for material characterization.
In addition, we already work closely and on an equal footing with many partner laboratories. This ensures that you receive the necessary documents quickly, in compliance with the standards and without any friction, thus achieving the approval of your medical device without any problems.
Give us a call, send us an email or fill out the contact form so we can