About UL
UL's pre-certification review take the guesswork out of designing for compliance and help to streamline the certification process.
Early consultation with a UL technical expert enables businesses to become familiar with the testing program and its requirements and may enable the identification of potential noncompliance issues and other obstacles before they become the source of costly and timely delays.
UL’s pre-certification review takes the guesswork out of designing for compliance and helps streamline the certification process. Customers can arrange for a pre-certification review as early as the design concept stage and all the way through to the last stages of the product development cycle.
UL's pre-certification review take the guesswork out of designing for compliance and help to streamline the certification process.
Early consultation with a UL technical expert enables businesses to become familiar with the testing program and its requirements and may enable the identification of potential noncompliance issues and other obstacles before they become the source of costly and timely delays.
Pre-certification reviews, also known as gap assessments, Stage 1 assessments, proactive reviews or preliminary reviews, are conducted by UL technical experts early in the design process either at the UL test facility or on site at a manufacturer's facility, typically to assess conformity to applicable standards for the desired markets. This service does not result in a UL certification.
Customers can arrange for a pre-certification review as early as the design concept stage and straight through to the last stages of the product development cycle. UL offers two service options: formal and informal.
Formal pre-certification reviews include a complete engineering evaluation of a product with a comprehensive report of the findings, providing actionable insight into how a product's construction may or may not meet the requirements of all applicable standards.
During an informal pre-certification review, a UL engineer provides expert insight, but no formal documentation (letter report) is issued. Informal pre-certification reviews can be conducted in person, over the phone or online via web chat.
Early consultation with a UL technical expert enables businesses to become familiar with the testing program and its requirements, and may enable the identification of potential noncompliance issues and other obstacles before they become the source of costly and timely delays.
UL experts can review the documentation for medical devices for compliance with any of the appropriate standards, quality system requirements or regulations. This includes human factor engineering protocols and user interface design; IEC 60601; home health devices; UL 61010; FDA test reports and submissions; submissions for China, Taiwan, Korea, Japan, EU Notified Body, RoHS II, eHealth and Health IT; ISO 13485; clinical and nonclinical test protocol and plans; and more.
UL technical experts can review a product from design to initial prototype to identify compliance issues prior to tooling, sourcing components and manufacturing to help reduce delays due to test failures, save costs in retooling and component sourcing, and provide a more predictable product launch.
Custom deliverable, depending on customer's needs
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