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
    • Safety, IEC 60601/ISO 80601, ISO 14708, or IEC 61010 
    • EMC, IEC 60601-1-2
    • Software, IEC 62304, and IEC 80001
    • Usability/Human Factors, IEC 62366
  • 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. 

More ThanYears Serving Our Customers! 2004 - 2014

What's New

  • NB Paper Clarifies, As Far As Possible In some ways, the advice in Annex ZA from EN ISO 14971:2012 can seem a bit like Don Quixote tilting at windmills and dreaming the impossible dream.  Do ...
    Posted Jul 2, 2015, 5:10 AM by Frank O'Brien
  • Photo-biological hazards in medical devices Photo-biological hazards need to be considered whether the medical device employs a light source for the medical purpose or a supporting function.  Examples of light sources in medical devices ...
    Posted Mar 27, 2015, 7:39 AM by Frank O'Brien
  • Deflated footballs and UOM Introduction Deflated footballs caused quite a stir during a semifinal championship game of the American National Football League (NFL). Based on a check by officials during halftime, it’s alleged ...
    Posted Feb 16, 2015, 2:06 PM by Frank O'Brien
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