Regulatory Compliance...

Comprehensive UL, CSA, FM Approval, FDA and FAA Regulatory Compliance Assistance.

CER design and regulatory division offers a full range of design, manufacturing and test compliance services when your products need approval from national and international regulatory agencies.

Working With Regulatory Issues

Products that require regulatory approval have added constraints placed on the methods and procedures used during the development process. The added regulatory requirements are typically directed towards the following:

• project organization - documented project phases, milestones, and the methods and procedures for approvals and for moving from one project phase to another.

• identifying project and technical risks, and methods of mitigating those risks.

• requirements testing - methods and procedures for tracking software and hardware requirements through the design and testing process to ensure that those requirements have been fully tested.

• formal methods and procedures for system validation testing.

• tracking control of project history, design methods, and progress through the design, testing, and acceptance process.

Listed below is a comprehensive list of services we offer our clients. Please contact us for more info.

Food and Drug Administration (FDA)

For specific information on FDA approvals, visit our page located here.

The primary FDA related documents detailing the design and development criteria are:

ODE Guidance for the Content of Premarket Submission for Medical Devices Containing Software

International Electrotechnical Commission (IEC) Medical Electrical Equipment Standard

General Principles of Software Validation, this document can be found at: CDRH Document Page


Underwriter Laboratories (UL)

For specific information on UL approvals, visit our page located here.

Underwriter's Labs (UL) related documents are:

UL 544 - Medical and Dental Equipment

UL 2601-1 - Medical Electrical Equipment, Part 1: General Requirements for Safety


Federal Aviation Administration (FAA)

For information on DO-178B go here.

The primary FAA related documents detailing the design and development criteria are:

DO-178B Software Considerations in Airborne Systems and Equipment Certification. This document can be ordered from: RTCA, Inc.