Every medical device (as well as the medical device constituent part of a combination product) that comes into direct or indirect contact with the human body is expected by regulators to undergo a biological safety evaluation, so as to determine the level of biocompatibility testing that needs to be performed as part of the V&V testing phase of product design. In many cases, these tests involve the commitment of significant time and monetary resources. It can often be of paramount importance to ensure that all required testing activities are done right on the first try, especially when raising new funds is a challenge.

This course provides practical working knowledge regarding how the biocompatibility testing that applies to a given medical device is determined and performed.  It explains the underlying mechanism for device-tissue interactions, the risks involved and how regulators have come to expect device manufacturers to present biocompatibility data to establish the acceptability of these risks. It  explains how biocompatibility testing should be integrated into medical device development projects, regulatory planning and clinical trial design.

The specific FDA and MDR requirements related to biocompatibility evaluation are presented, and the testing scheme presented in the internationally recognized standards family, ISO 10993, is thoroughly discussed.

Finally, the ISO 18562 family of standards is described. These standards present a unique set of biocompatibility requirements that are applicable to medical devices which are intended to provide respiratory care or to supply substances via the respiratory tract to a patient.