Speed Up Your Medical Device Regulatory and Safety Approvals


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.



Helping our clients through risk management and compliance issues from design to implementation.


Verifying your design to applicable standards.


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

  • 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
  • A FAQ for medical equipment with intentional radios Some terms:TermMeaningIntentional radioradio transmitter such as for WiFI, Bluetooth, RFID, cell phonesR&TTEDRadio and Telecommunication Terminal Equipment Directive, 1999/5/ECREDRadio Equipment ...
    Posted May 31, 2016, 9:19 AM by Frank O'Brien
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