UL Life and Health Sciences offer a full range of medical device testing to support your needs. From design to aftermarket, our engineers are able to test the safety and help mitigate the risk for devices, wearables, combination products, and cybersecurity.
Pre-compliance – Pre-evaluation and testing allows you to partner with UL early in your product development cycle. From training to gap analysis to custom testing, we can do as much (or as little) as you need to help you meet you project timelines, keep costs down, and increase the likelihood of discovering any potential issues early in design and production.
Compliance – Third-party testing and certification (compliance) is what UL is founded on. From electrical safety to human factors to cybersecurity to non-clinical, we are experts in evaluating products to global standards. During the evaluation process, as potential non-compliances are encountered, we will tell you what the specific requirement is and reference the standard as well as explain why the product does not meet the requirement. As you develop possible “fixes,” our engineers will work with you to meet the requirements.
Verification/ Validation – This is one of the key steps in the Medical Device and Laboratory Equipment life cycle. UL supports manufactures in different stages of product life cycle process to help brands and manufacturers confidently stand out from the crowd with trusted, independent confirmation of key product features, sustainability efforts or service benefits.
Batch – To support CE certifications to the In-Vitro Diagnostics Directive, List A devices require batch verification testing. UL has established an efficient batch-testing process for manufacturers of the devices. Working with the Paul Ehrlich Institute, we are able to offer the highest-caliber testing services across the whole range of List A devices.
RA/QA – UL utilizes in-house auditors who deliver value, consistency and confidence for both your business and your customers. You will have a consistent audit experience and the benefit of auditors with years of expertise in the medical field, so you have less time “training” the auditor in the complexities of the medical industry. UL auditors are located in the major medical markets around the world, reducing travel time and increasing the ability to communicate real time in the local language.
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**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.