As of Dec. 2003, all four US manufacturing sites of Amcor Flexibles Healthcare are registered to ISO 13485, the quality system specific to medical devices. Jan 31, 2004 Under ISO 13485, more ...

South African Health Products Regulatory Agency (Sahpra) has indicated that ISO 13485 certification is a prerequisite for the application or renewal of a medical-device license, with effect from 1 ...

The FDA proposed on Feb. 22, 2022, an update to the Quality System Regulation 1 that was released in 1996. The proposal is to reference ISO 13485:2016 Medical devices — Quality management systems — ...

Royalty-free licenses let you pay once to use copyrighted images and video clips in personal and commercial projects on an ongoing basis without requiring additional payments each time you use that ...

Royalty-free licenses let you pay once to use copyrighted images and video clips in personal and commercial projects on an ongoing basis without requiring additional payments each time you use that ...

It has only been modified to comply with this publication’s space and style. Performance Motion Devices, Inc. (PMD) announced that it has received ISO 13485:2016 certification for all of its ...

The 2003 edition of ISO 13485 has now been withdrawn and fully replaced by the 2016 edition.[i] As a result, a technical report on the 2003 edition, ISO TR 14969, also was withdrawn and replaced by a ...

CONCORD, Calif., June 13, 2018 /PRNewswire/ -- Pulse Systems announced today that the Company's ISO 13485 and ISO 9001 certifications have been successfully updated to the latest revisions of both ...