March 31, 2017

FDA issues FAQs on MDSAP

In late March, US FDA released a 36-page document containing frequently asked questions (FAQ) on the Medical Device Single Audit Program (MDSAP). The 96 FAQs are organized around three major areas, General, Assessment related and Audits and contain multiple links back to other documents, including the IMDRF documents. Relationships to WHO, ISO 13485, NRTL and… read more

March 31, 2017

UL Achieves Transition Accreditation for the 2016 Version of ISO 13485

Medical device customers can now receive audits and certificates to ISO 13485:2016 to align with global regulatory requirements. >> Click here to view the press release version.

February 24, 2017

EU Medical Regulations Published

On February 22nd, 2017, the texts of the EU Medical Device Regulation and IVD Regulations were published. With the publication, the process for transition is now moving forward. The European Council will meet on March 7th and then the EU Parliament (ENVI) will meet March 20th . Following that the Parliament meets in April and… read more

February 24, 2017

Latest updates from the TC 62 JWG 14 meeting in Berlin

November 15, 2016

UL signs MoU with Seoul National University Hospital