Safely achieving successful applications and products

According to ISO 10993-1, a medical device manufacturer is obliged to carry out an assessment and examination of biocompatibility as part of a risk management system in the event of direct or indirect contact of his product with the patient, doctor or third party.

We generally recommend that customers do the following for new products:

  • Biological assessment plan as part of the risk management plan
  • Biosafety testing
  • Biological assessment - summary and qualified risk assessment

We advise our customers and work with them to develop a strategy for assessing biological safety. We are guided by the requirements of 10993-1 in doing so. We provide assistance on the approval procedures of different countries and point out the differences that mainly form the decision criteria for the respective strategy.

Our scientists will work with you to develop a comprehensive test strategy that is suitable for your product and for subsequent approval.

On the basis of the biocompatibility tests, literature searches and risk analysis carried out, we prepare a biological assessment for the regulatory approval or conformity assessment.

Our scientists have years of expertise in the field of biocompatibility and are on the expert committee of DIN "NA 027-02-12 AA biological evaluation of medical devices" and ISO/TC 194. This gives them a good insight into current standardisation work in the field of biocompatibility. In addition, our scientists have extensive and personal experience in clinical research and the development of new medical devices. This predestines them for teaching at German universities, for consulting activities and for providing conducting seminars.

Your contact persons

Should you have any questions about our services, please do not hesitate to contact us.

Herr Dr. Norman Layh
Dr. Norman Layh
Business Development
Frau PD Dr. Andrea Nolte-Karayel
PD Dr. Andrea Nolte-Karayel
Packaging + Biocompatibility

BBF Sterilisationsservice GmbH
Willy-Rüsch-Str. 10/1
71394 Kernen-Rommelshausen
+49 7151 94570 -0
+49 7151 94570 -12