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

  • 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
  • Keeping up with the effective dates FDA and EU effective dates Here’s a summary of upcoming FDA and EU effective dates for common Medical Electrical Equipment safety standards Medical Electrical Equipment Standard FDA effective date ...
    Posted Jul 6, 2016, 9:10 AM by Frank O'Brien
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