Medical Device TestingThe BDC Labs team has over 35 years of experience in medical device product research, development, and testing. Our focus is on functional, engineering based, testing of medical devices including Class 2 and Class 3 devices. The BDC team actively participates in The American Association of Medical Instrumentation (AAMI), the International Standards Organization (ISO) and ASTM Endovascular Device and Stent Standards Committees. As participants on these committees, BDC personnel have a unique understanding of developing medical device testing and verification plans, along with protocols to support FDA and CE Mark submissions on many types of medical devices. BDC has a fully established quality system based both on Good Laboratory Practices (GLP), as well as accredited to ISO/IEC 17025:2017.
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“BDC is a great, reliable contract laboratory. They exhibited great technical proficiency and tailored the test protocols to our specific samples. The customer service was exceptional as well. They worked with us to accommodate our timelines despite receiving a portion of the test samples last minute.” Read more »
Medtronic (Cardiac Division), Inc.
Benefits & Capabilities
- Team active in international standards development
- Extensive experience in FDA and regulatory submissions
- Rapid turnaround times on all activities
- Established and audited GLP testing capability
- Extensive product development experience
- Complete confidentiality