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

  • 2016 Training Schedule   Galway Ireland 5-7 April, London England 10-12 May, San Francisco CA USA 21-23 June, Boston MA USA 18-20 October,Click here for Registration and more information
    Posted Feb 1, 2016, 12:42 PM by Debra Carlson
  • 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 Dec 9, 2015, 11:27 AM by Frank O'Brien
  • 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
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