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Explore educational resources about the testing solutions needed to get your device to the next stage along with important administrative forms so you can be setup for success.


Biocompatibility Matrix

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Preclinical and Experimental Surgery Solutions

Biocompatibility endpoints required for assessment as a part of a risk based evaluation of medical device safety are provided by ISO 10993-1 and various international regulatory body standards and guidance documents.  The endpoints detailed in the matrix table describe the potential risks based on the clinical contact type and duration of the medical device to the patient or clinician.  Devices may fall into multiple categories based upon the various components (delivery system and implant), and it is important to consult all available applicable standards and guidance documents which may provide other specifics to the medical device biocompatibility evaluation process.   Each endpoint for evaluation should be identified as a part of a biological evaluation plan (BEP).



Acronym Agency/Term/Organization
FDA Food and Drug Administration
EPA Environmental Protection Agency

International Standards Organization

ISO/IEC 17025:2017 – ANAB

USDA United States Department of Agriculture
MSPCA Massachusetts Society for the Prevention of Cruelty to Animals
AAALAC International Association for the Accreditation of Laboratory Animal Care and Use
OLAW Office for Laboratory Animal Welfare
DEA Drug Enforcement Agency
MWRA Massachusetts Water Resource Authority
EPA Environmental Protection Agency - Hazardous Waste Division
MA-DEP Department of Environmental Protection
MA-DPH Massachusetts Radiation Control Program
NRC Nuclear Regulatory Commission
CLIENTS Medical Device, Pharmaceutical Chemical Manufacturers

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