Take control of product certification
How to stay on top of demand by reducing the turn-around-time at the test houses
When it comes to regulatory compliance, all medical products require specific activities to be included in the design plans. Complex designs involving extensive risk management, programmable systems (software), and specialized technologies further compounds these compliance activities. While safety standards allow for revision of design plans during project evolution, the pragmatic approach is to introduce compliance engineering into the beginning phases of the design process.
By doing so, the certification becomes more efficient, manageable and predictable. Significant control over the certification work is shifted back to the contract designer and/or manufacturer because compliance has been document prior to the formal submittal to the test house. The submission to the certification body then becomes a final review of compliance reports rather than the start of a new investigation with a finished device. UL’s experienced teams can enter/exit through any phase of development, providing compliance engineering solutions.
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