Regulatory Agency Approvals

It’s a regulated world and we are experts at winning agency approvals in several areas.

Our expertise allows us to design compliance in from the start rather than cross our fingers and iterate the design and test and re-test when a product is suppose to be shipping. The following are examples some of the standards we’ve met:

Regulatory Standards:

• UL, IEC and AMMI for Medical Devices (60601-1...)
  
• Risk Management
  
• IEC Industrial and Laboratory Safety
  
• IEC Maritime System
  
• IEC Laser Products Safety
• Federal Communications Commission (FCC) for EMC
• FCC for Phoneline
• National Electric Code
• Federal Election Commission (FEC) Standards
• Automotive

We also follow our ISO 9001 and ISO 13485 certified design control processes to ensure the proper steps are taken to win FDA or other regulatory approval to market your device.