UL provides active and inactive medical device manufacturers with a complete offering of third-party regulatory approvals, product testing and certification, auditing, cybersecurity testing, usability testing, and the training to support your compliance challenges.
Validation/ Verification Report – UL determines the accuracy of marketing claims related to the performance, functionality or features of products, facilities, processes and systems that consumers or end users are unable to easily assess on their own. Our claim verification service is based on rigorous, repeatable and independent assessments. Companies that successfully have a claim verified by UL are eligible to use the specially created UL Verified Mark to showcase that their claim is backed by an objective, science-based process leveraging our trusted technical expertise and capabilities.
Summative Test Report – Plan, conduct, and report the results of a summative (i.e., validation) usability test of the market-ready product to validate that it meets the user requirements and ensures safe and effective use. Summative usability tests can be designed to meet applicable regulatory requirements (e.g., ONC safety-enhanced design requirements; or in support of FDA submission and/or CE marking).
Human Factors Engineering Report – UL works with our clients to establish a guiding vision of how the intended users (e.g., healthcare professionals, administrative personnel, and patients) will interact with a product and conceptualize all of the touch points that will contribute to the full user experience.
Cybersecurity Assessment Report – Will help identify assets, threats, and vulnerabilities and assess of the impact of threats and vulnerabilities on the device functionality and end users/patients and assess the likelihood of a threat and of a vulnerability being exploited. Performing this analysis will help to improve the cybersecurity hygiene of your product that will meet industry best practices that align with HDO expectations, UL 2900, NIST framework and TIR-57.
Informative Test Report – For many countries and/or regulatory bodies, an informative test report may be all you need. UL can assist by performing the evaluation to EN (European Norm) or other appropriate standards and issue an informative test report. Though a third-party report may not always be required, it may be desirable to mitigate risk, liability and can be used as market differentiator.
TO SPEAK WITH OUR INDUSTRY LEADERS AND TAKE ADVANTAGE OF A PERSONALIZED, NO-OBLIGATION ANALYSIS, CLICK HERE.
**As a Notified Body, MDSAP Recognized Auditing Organization and ISO 17000 series accredited Certification Body we cannot participate in the design, manufacture, installation or distribution of the products we certify or provide consultancy services related to those products. In addition, the UL Notified Body cannot provide certification services to companies that have been provided with consultancy services from other companies in the UL family. We also cannot link our activities to the activities of organizations that provide consultancy services. If you require such services please use an internet search engine to identify relevant providers.