Medical Device Safety Consulting and Testing Services

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

Expertise

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.

Services

Consulting

Helping our clients through compliance issues from design to implementation

Testing 

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

Training

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

  • 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
Showing posts 1 - 3 of 18. View more »