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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

  • What’s the 4th Edition of IEC 60601-1-2 all about? OBCM has released an impact analysis overview for the new 4th edition of IEC 60601-1-2:2014, the medical electrical equipment/systems electromagnetic safety standard.  Explained are:Key changes ...
    Posted Apr 18, 2014, 10:05 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
  • Better integrate IEC 60601 safety into your design process OBCM has 2 IEC 60601 training sessions starting soon.  One will be in Boston, 15-17 Apr 2014.  The other in San Jose, 29 Apr-1 May.  In the fall ...
    Posted Mar 21, 2014, 10:29 AM by Frank O'Brien
Showing posts 1 - 3 of 12. View more »