Biocompatibility compliant with ISO 10993

Prove the biocompatibility of medical devices quickly, inexpensively and without animal testing

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

a) Support in the development and production of your medical device

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:

• Product development: Material selection, preliminary tests, influence factors,…
• Evaluation of biocompatibility: Review of evaluations, worst-case scenarios, re-evaluations, problem cases,…
• Batch releases: Test interval, test quantity, transferability, test selection, pricing,...
• Review production process/final product cleaning focusing on critical aspects: production aids, cleaning agents, cause analysis,...
• Mastery of problem cases: Deviations in batches, incidents in the production process,…

b) Support in the decision between insourcing versus outsourcing

Are you 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?

• We will work out together if/when it will be worthwhile for you.
• We take care of an optimal integration into your QM system.
• Together with you, we implement interfaces to your outsourcing partner and ensure uncomplicated, effective and efficient communication.

b) Would you like to update or develop your know-how?

• We create/review all necessary templates and structures for you.
• We implement them and train you on-site.

We tailor everything individually to your specific product and your company.

c) Support in the selection of external test laboratories (ISO 10993)

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

• understand your task,
• if required, agree a confidentiality agreement,
• prepare a tailor-made offer and
• support you as quickly, competently and cost-effectively as possible.