Expertise: Regulatory Compliance

Definition

Many devices must comply with safety standards. Medical devices, especially, require extensive documentation to demonstrate compliance.

Our Expertise

There are dozens of regulatory agencies, and hundreds of regulatory standards that apply to engineered devices.  A few of the more recognizable are:

  • ISO-13485:  Medical devices
  • UL and IEC:  Electrical safety
  • NFPA:  Fire safety and hazardous locations
  • FCC:  Wireless communications
  • MIL810:  Toughness in harsh environments

 

Nearly every product that Porticos develops must comply with one or more regulatory standards.  We have broad experience with many, and know how to get up-to-speed on new ones.

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