Speed Up Your Medical Device Regulatory and Safety Approvals

Expertise

Medical devices, use scenarios, technologies

  • Surgical instruments (HF, laser), 
  • Radiation therapy (gamma, electron, proton), 
  • Robotic surgical platforms, 
  • Imaging (x-ray, ultrasound, MR), 
  • Endoscopes, 
  • Catheters, 
  • Surgical navigation (IR, EM), 
  • Physiological monitors, 
  • Pumps, 
  • Active implants, and
  • IVD devices.  

International standards

  • Safety, IEC 60601/ISO 80601 series,
    ISO 14708 series, IEC 61010 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 risk management and compliance issues from design to implementation.

Testing 

Verifying your design to applicable standards.

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

What's New

  • Frank retiring Frank O'Brien, our founder, will be retiring from active consulting and testing starting in Jan 2018. The company will remain a provider of IEC 60601 training services. Frank will ...
    Posted Oct 31, 2017, 8:26 AM by Frank O'Brien
  • What's New for Medical EMC? Amendment underway to the Electromagnetic Disturbances standard Early 2017, work began on Amendment 1 to IEC 60601-1-2:2014, edition 4.0, the medical electrical equipment collateral standard for ...
    Posted Sep 12, 2017, 12:02 PM by Debra Carlson
  • New 2017 Training Schedule Our Training for Integrating medical device safety into the design processIEC 60601/ISO 80601, ed 3.1 and 2.2 families will be held in 3 locations this year ...
    Posted Sep 14, 2017, 8:43 AM by Debra Carlson
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