Software certification for Medical Devices
Software is an essential component in the functionality and usability of many electromedical devices. It can also provide critical safety protection and control essential performance of a device. As such, regulatory bodies around the world require manufacturers to document and control the software installed in medical products. As a leader in safety certification, UL supports the industry with software certification services that can be delivered by the same engineering experts that are assessing your device to mechanical, and electrical safety.
UL Services for Medical Device software
- Software certification for medical devices according to IEC 60601-1
- Software certification for medical devices according to IEC 60601-1-4 2nd edition
- Software certification for global regulatory technical file submissions
- Audits to software process system standard, IEC 62304
- Risk management assessment to ISO 14971, which is referenced in IEC 62304 and IEC 60601
The Advantage to working with UL
- Experience: UL history of establishing ANSI/UL 1998 as one of the first FDA Recognized Consensus Standards under the 510k, PMA, IDE processes
- Global Acceptance: UL test reports are accepted by regulatory bodies around the world
- UL Staff have years of experience with software certification
- UL Software experts are located in our offices around the world
Additional resources
- NEW Article: "Software Verification and Validation - The Role of IEC 60601-1" (Registration Required)
This article was originally published in the September/October 2011 issue of Biomedical Instrumentation & Technology (BI&T), a bimonthly, peer-reviewed journal from the Association for the Advancement of Medical Instrumentation, www.aami.org. Posted with permission from AAMI. Any other distribution of AAMI-copyrighted material requires written permission from AAMI.
