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Medical Device Safety Testing and Consulting Services

Speed Up Your Regulatory and Safety Approvals

Solutions... Approvals... Training...

manage risk & usability
Why OBCM?

  • Expert, Responsive Engineers 
  • We know what works; the pitfalls to avoid
  • Design for compliance 
  • Your risk, usability, and software development processes in compliance 
  • Medical device safety testing -- Fully equipped Boston based laboratory
  • Test reports that support FDA, CE Mark, and OSHA NRTL/Can Certification -- accredited as a TÜV Rheinland Partner Test Laboratory 
  • Close partner network for other needed services: EMC, Shock & Vibration, Transport, Ingress, Ultrasound, Light, Quality Systems

FDA                  TUV Certification

Let us help you with your medical device development -- the earlier, the better. 


What's New

  • A Simple Trick that Safety Test Labs Don’t Want You to Know! Important Changes Made to IEC 660601-1 Test Report Form, Ver iOn July 4th 2014 a new version i of the IEC 60601-1 Test Report Form (TRF) was ...
    Posted Sep 9, 2014, 1:43 PM by Debra Carlson
  • What’s the 4th Edition of IEC 60601-1-2 all about? Jim Conrad and OBCM have released an overview and impact analysis for the new 4th edition of IEC 60601-1-2:2014, the medical electrical equipment/systems electromagnetic safety standard ...
    Posted Apr 21, 2014, 7:16 AM by Frank O'Brien
  • Safety Integrity Levels (SIL) and Medical Systems OBCM has released new guidance to help medical system designers employ Safety Integrity Level rated motor controllers into the motion control systems typically seen in Medical X-ray, magnetic resonance ...
    Posted Apr 14, 2014, 5:07 PM by Frank O'Brien
Showing posts 1 - 3 of 13. View more »