A Notified Body is approval is required for higher risk medical and IVD devices in the EU. This business relationship is intended to be long-term and it’s best to be prepared. UL Notified Body staff have collaborated on an article titled “Critical Things to Consider When Looking for a Notified Body” that lists the top 11 things… read more
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UL Northbrook expands CBTL scope with 3 additional IEC 60601 Medical Particular Standards for use with IEC 60601
UL has expanded its scope at its Northbrook, IL laboratory and can now offer IECEE CB Scheme testing, reports and certificates to three ISO 80601 Particular standards. ISO 80601-2-35:2009 Medical electrical equipment — Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for… read more
PRE-RECORDED WEBINAR: Business Impact of the new EU IVD Regulation – An Executive Brief with Sue Spencer
About this webinar: In this 30-minute pre-recorded webinar, Head of UL Global Medical Device Services, Sue Spencer shares her expertise in what to expect from a business standpoint for the new EU IVD Regulations. The European Union IVD “revolution” has been in motion since 2012. Many of the larger companies are already putting the systems… read more