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Regulatory Requirements and Approvals
Many products require regulatory approval prior to marketing and sale. We can provide
design, technical, and project management assistance for products that require approvals.
We have expertise in the following areas:
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Underwriter's Laboratory (UL)
product approvals. UL Listing Mark - found on many commercial, industrial and household
products. |
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The International EMC mark appears
on products meeting the electromagnetic compatibility requirements of Europe, the United
States, Japan. Medical and dental equipment, computers, microwave ovens, televisions,
radios, transmitters, and radio controlled equipment are subject to EMC testing and
regulatory requirements. |
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The CE (Conformité Européenne)
Marking is required to be displayed on regulated products placed for sale on the European
market. It indicates that a product complies with applicable European Directives, which
are European related to health, safety, environment and consumer protection. Because the
CE Marking identifies products that meet a common set of criteria established and adopted
by the 18 member countries of the European Economic Area (EEA), the CE Marking on your
products will permit them to move freely in commerce throughout the European market. |
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FDA Approvals - we can provide
design and technical assistance for product development, testing and generation of
technical documentation. Product approvals require strict conformance to established
design procedures, project management activities, risk assessment methods, and
verification and validation procedures. We can provide professional assistance in all
these areas. |
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RTCA/DO178B Approvals - we can provide
design and technical assistance for product development, hardware and
software design, verification and validation testing and generation of
technical documentation. Product approvals require strict conformance to established
design procedures, project management activities, risk assessment methods, and
verification and validation procedures. We can provide professional assistance in all
these areas. |
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Directive of Waste from Electrical and Electronic Equipment
(WEEE), proposes to ban substances the EU deems environmentally hazardous in
electrical and electronic assemblies imported into its member countries. The
directive would also require manufacturers to recycle products at the end of
their life cycles.
Lead, which is widely used in component finishes, solder, and
printed-circuit-board pads, is the main substance to be affected by the
proposed ban. Others include mercury, cadmium, chromium, and polybrominated
biphenyls and diphenyls. |
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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:
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project organization -
documented project phases, milestones, and the methods and procedures for approvals and
for moving from one project phase to another. |
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identifing project and technical
risks, and methods of mitigating those risks. |
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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.
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formal methods and procedures for
system validation testing. |
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tracking control of project
history, design methods, and progress through the design, testing, and acceptance process.
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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:
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ODE Guidance for the Content
of Premarket Submission for Medical Devices Containing Software |
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International Electrotechnical
Commission (IEC) Medical Electrical Equipment Standard |
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General Principles of Software
Validation, this document can be found at:
CDRH Document Page
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Underwriter Laboratories (UL)
For specific information on UL approvals, visit our page
located here.
Underwriter's Labs (UL) related documents are:
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UL 544 - Medical and Dental
Equipment |
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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:
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DO-178B Software
Considerations in Airborne Systems and Equipment Certification. This document can be
ordered from: RTCA, Inc.
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