Medical Device Safety Consulting and Testing Services

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


We are foremost experts in medical devices including surgical instruments, physiological monitors, radiation therapy, robotic surgical platforms, imaging, endoscopes, catheters, and active implants and their technologies.  We have expertise in all the applicable international standards including safety, IEC 60601/ISO 80601 series; risk, ISO 14971; EMC, IEC 60601-1-2, IEC TR 60601-4-2; software, IEC 62304; and usability, IEC 62366.



Helping our clients through compliance issues from design to implementation


Verifying your design to applicable standards so that your product is safe to market


Explaining the complexities of integrating medical device safety into your design process, equipping your team with the tools they need to move forward

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

  • Shocktober 2015 Presentation of What's New Thanks to the over 40 people who attended and made this year's open house a great success.  We certainly appreciate the time everyone took to stop by and share ...
    Posted Nov 5, 2015, 6:26 AM by Debra Carlson
  • Future medical robot safety requirements Surgical robotic systems hold the promise of enhancing the capabilities of surgeons performing surgery with advantages such as smaller openings, and more precision. There can be less blood loss, improved ...
    Posted Sep 15, 2015, 9:21 AM by Frank O'Brien
  • 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
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