For Medical Devices

Scientific expertise

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 set up for success.


 

Featured Content

Biocompatability explained - A primer and refresher

Labcorp's coffee talk presentation and MD&M West 2023

Infosheets

Biocompatibility endpoints evaluation

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).

Certifications

AcronymAgency/Term/Organization
FDAFood and Drug Administration
EPAEnvironmental Protection Agency
ISO

International Standards Organization

ISO/IEC 17025:2017 – ANAB

USDAUnited States Department of Agriculture
MSPCAMassachusetts Society for the Prevention of Cruelty to Animals
AAALACInternational Association for the Accreditation of Laboratory Animal Care and Use
OLAWOffice for Laboratory Animal Welfare
DEADrug Enforcement Agency
MWRAMassachusetts Water Resource Authority
EPAEnvironmental Protection Agency - Hazardous Waste Division
MA-DEPDepartment of Environmental Protection
MA-DPHMassachusetts Radiation Control Program
NRCNuclear Regulatory Commission
CLIENTSMedical Device, Pharmaceutical Chemical Manufacturers