ISO 13485 Update: Worries About Firms Missing 2019 Deadline; Quality Systems Standard Handbook In The Works; Suppliers Now Eligible For Certs – And More
This article was originally published in The Gray Sheet
Executive Summary
Device manufacturers might be tempted to put off becoming certified to the newly revised ISO 13485 because they've been given three years to conform to the global quality systems standard. But not so fast, says ex-FDA official Kim Trautman, who's worried that ISO's three-year window for companies to comply will "lull people into a false sense of security": "Not every firm has three years, per se, to transition from the 2003 version of ISO 13485 to the 2016 version; some firms might only have one year depending on how their certifications are laid out," she warns. Meanwhile, ISO is authoring a handbook to the revised standard, and Trautman talks about what firms should keep an eye on in the rejiggered standard, including its scope – which now allows vendors to be certified to the standard – and sections on compliant handling, purchasing activities and risk. Also: a podcast interview with Trautman, who talks about her worries that firms will miss ISO's March 2019 deadline.
You may also be interested in...
Device Firms Invited To Join MDSAP Ahead Of 2017 Full Launch
Medical device firms are being invited to participate in the international single audit program, which will enter the operational phase next year.
Colorado Price Cap Plan For Enbrel Draws Amgen Lawsuit; Cosentyx, Stelara ‘Affordability’ Reviews Pending
However, the state's recently formed prescription drug affordability board found Gilead’s Genvoya and Vertex’s Trikafta to be affordable.
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.