General Testing ServicesBDC Laboratories specializes in medical device testing, research and development (R&D) support and functional product evaluation of both Class 2 and Class 3 medical devices worldwide. With our highly trained and technical personnel, BDC Laboratories excels in constructing and executing test programs for established technologies or ones that do not fall into the classical definitions within the guidance documents and regulatory agencies.
Test Plan and Protocol Method DevelopmentIn addition to helping assemble the FMEA / Hazard Analysis for your medical device, BDC Laboratories can assist you in the development and evaluation of comprehensive testing plans and protocols that will demonstrate mitigation of a potential failure mode or source of harm. In development of the test protocol, either ASTM or ISO test methods can be used as the foundation or where none exist; our highly technical team can develop and validate a method that best suits the test objective.
Test Execution and Data AnalysisOnce the protocol is developed and the test method is validated, BDC Labs can execute the test per Good Laboratory Practices and compliance with ISO 17025. All test equipment is NIST traceable calibrated as part of our commitment to accuracy. Finally, at the conclusion of the test, all data will be reviewed and analyzed with the appropriate statistical methods and verified by our internal quality assurance personnel.
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Medical Device Testing
Comprehensive stent and stent graft testing programs are available based on ISO 25539, including durability, and the FDA’s Guidance Document 1545. Read more »
Comprehensive vascular graft and A/V access graft testing programs are available based on ISO 7198 in its entirety. Read more »
BDC Labs offers comprehensive testing programs based on ISO 10555 and ISO 11070 in their entity, as well as the FDA Guidance Document 824. In addition, BDC offers dialysis catheter testing, including recirculation quantification. Read more »
Heart valve durability and hydrodynamic testing activities are available based on the ISO 5840 guidance document. Read more »
Fully validated Coating Integrity & Particulate Testing capability for stents, catheters and guidewires per ASTM 2743 and FDA Guidance Documents. Read more »