Among all the hurdles that the legislator has set up before medical devices can enter the market, the proof of biocompatibility poses particular challenges. Specialized service laboratories have an impressive number of corresponding tests in their repertoire: But which of these does your medical device really need?
In principle, the answer to this question is provided by EN ISO 10993, but since a wide variety of medical products ranging from plasters to pacemakers are regulated in this standard, the central question is how the regulations are to be interpreted in individual cases. The composition of materials and substances, their production, interaction with the packaging, application duration, contact time, available data, literature data and many other aspects are too different and too complex for the question of biocompatibility to be answered with simple if/then formulas.
Another pitfall: The test results provided by the laboratory are not sufficient to prove the safety of your product. Only in the form of a standard-compliant report do they develop regulatory usefulness.
We at TentaConsult will guide you safely through the jungle of EN ISO 10993 regulations.
We deal with your medical device in detail, or even better with your product idea. Because it is worthwhile to keep biocompatibility in mind already during the product development. A wise choice of materials makes it possible to plan the effort for the tests!
We develop a customized, risk-based biocompatibility strategy for your medical device – a Biological Evaluation Plan (BEP). With this plan for an efficient test strategy and our partner laboratory TentaMedix at our side, we will prepare the results for you in a Biocompatibility Evaluation Report (BER) that conforms to standards: For a meaningful biocompatibility proof from one source, individually for your product and without friction losses.
With TentaConsult your biocompatibility evaluation is in experienced hands: Let us work together individually for your product!
Your contact partner:
Senior Consultant Medical Devices
+49 251 928715-62