Medtech Insight is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

Advertisement

Related Content

Device Firms Invited To Join MDSAP Ahead Of 2017 Full Launch

Topics

Advertisement
UsernamePublicRestriction

Register

MT034681

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

All set! This Question has been sent to my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel