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

  • Thanks for coming.... Thanks to everyone who came out to our open house always a nice time and a little info/education as well. For those of you who missed it here is ...
    Posted Oct 27, 2016, 1:00 PM by Debra Carlson
  • OBCM Open House Shocktober Wednesday October 19, 20165pm to 8pmWe cordially invite you to join us for our annual Open HouseFrank O'Brien will give a brief talk on regulatory ...
    Posted Sep 29, 2016, 9:05 AM by Debra Carlson
  • EM Safety; EU and FDA effective dates The FDA recently extended the effective date for the EM Disturbances collateral, IEC 60601-1-2:2014, 4th edition, to align the date with the recently announced EU harmonized standard ...
    Posted Aug 3, 2016, 11:34 AM by Frank O'Brien
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