Medical Device Safety Consulting and Testing Services

Speed Up Your Regulatory and Safety Approvals
Solutions... Approvals... Training...

risk estimation

  • Expert, Responsive Engineers
  • We know what works; the pitfalls to avoid
  • We support compliance with
    • Risk, ISO 14971
    • Usability/Human Factors, IEC 62366
    • Software, IEC 62304, and IEC 80001
    • Safety, IEC 60601/ISO 80601, ISO 14708, or IEC 61010 
    • EMC, IEC 60601-1-2
  • Gain FDA, CE Mark, and OSHA NRTL/Can approvals
  • We have a close partner network for other needed services

FDA                  TUV Certification

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

Years Serving Our Customers! 2004 - 2014

What's New

  • Shocktober Open House 2014 Come and help us Celebrate 10 years! October 23rd at 5:00pm  73 Princeton Street Suite 207 North Chemlsford MA Sign up here to attend  Enjoy some good food, drink ...
    Posted Oct 16, 2014, 10:28 AM by Debra Carlson
  • O'Brien Compliance 10 year Anniversary and Open House Come and celebrate with us, our ten year anniversary this October 23rd at our Annual Open House. For the past ten years OBCM has specialized in providing testing, consulting, and ...
    Posted Sep 30, 2014, 10:46 AM by Debra Carlson
  • A Simple Trick that Safety Test Labs Don’t Want You to Know! Important Changes Made to IEC 60601-1 Test Report Form, Ver jOn July 4th 2014 a new version j of the IEC 60601-1 Test Report Form (TRF) was ...
    Posted Oct 30, 2014, 7:39 AM by Steven Deibele
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