Medical Devices Certification Transfer Program
UL utilizes your existing report and recognizes processes in place for regulatory compliance to provide manufactures with a streamlined process to transfer to UL.
Find out more - Recording of LIVE WEBINAR! Click here to view it now.
With trade globalization, standards harmonization and design innovation, the medical device industry has become more competitive than ever. The United States is the largest single country consumer of medical devices in the world and medical device manufacturers need every advantage for differentiation in this highly competitive market.
The UL Brand adds value
With over a 117-year history in safety science, the UL Certification Mark delivers peace of mind to you and your customers, who know that it represents safety and trust. In addition to high consumer awareness, the UL Mark brings value when installing your medical device in the U.S. because 97% of Authorities Having Jurisdiction (AHJs) are more comfortable accepting the UL Mark over any other mark. This may be just the competitive edge you need.
New process makes converting your medical report to UL easier than ever
With all the regulations in place for medical device approvals, medical devices are held to a higher standard than most consumer products. That's why UL is aligning our processes with industry norms and regulatory requirements using risk-based assessments to identify and mitigate potential hazards for end product medical devices.
Simple conversion overview
It can be as simple as giving UL your current test report, a sample and your risk management file. UL expert engineers will review the data for scope, potentially conduct test checks and if all is in compliance with the IEC 60601-1 standard, UL will transfer your file and you can start to place the UL Certification Mark on your product immediately.
Advantages to Using UL
- Full Lifecycle Service - UL provides testing and advisory services from product ideation to post-market
- Global Market Access - UL services are aimed to support medical device manufacturers place safe products in the market
- Trust - For over a century, the UL Mark has stood for integrity and trust and 82% of U.S. manufacturers surveyed agreed that UL is a trustworthy company.
- Global Offices - UL has experts and staff around the world, in local time zones and languages giving you access to a local and dedicated contact to work with on an ongoing basis
- Integrated Assessments - UL provides concurrent assessments and test plans to meet global regulatory requirements, giving you access to multiple markets while avoiding retesting..
Additional Resources:
- Link to Press Release for Medical Device Certification Transfer
- Link to dedicated page for 60601 3rd edition
- Link to recording of live webinar explaining the UL Open Access program
Contact:
Find out more about using your existing IEC 60601-1 test reports to get the UL Mark and other ways UL is coming up with innovative ways to support Global Market Access for medical devices. To request the sell sheet or a quote, contact your local UL office or email Medical.Inquiry@Ul.com
