Results 3 found
May 27th, 2014
EU Requires 60601 with Amendment 1 after 12/31/17

On May 16, 2014 the EU updated the Official Journal for the Medical Device Directive.  One of the updates was to include the EN versions of 60601-1 with Amendment 1.  After 12/31/2017, customers using the 60601-1 standard as a presumption of conformity will need to use the EN 60601-1:2006/A1:2013. For more information on the EU… read more

March 10th, 2014
UL Experts provide insights into HFE and medical device design in the January issue of Medical Design Briefs

UL’s Linda Chatwin, Maureen Mulcare and Jeff Rongero, recently published an article in Medical Design Briefs titled “Safety and Human Factors Engineering in Medical Device Design.” As the article states, “Ultimately, manufacturers must validate that the product’s users can employ the device safely and effectively in the intended use environments” which is why Usability is… read more

January 29th, 2014
UL’s Notified Body Toolkit

The EU is one of the most attractive markets for medical device and IVD sales. UL’s Notified Body toolkit provides 34- pages of information on the EU regulatory system, including the classification rules, process for approvals and conformity assessment procedures. It also is a valuable reference document, with links to guidance documents, Interpretive documents and… read more