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

QUOTED. Aug. 21, 2018. Kim Trautman.

Executive Summary

When FDA rewrites its Quality System Regulation, it will have to consider satellite device rules that address complaints, product recalls and traceability – just to name a few – to make sure those requirements will still be met by device-makers. So says Kim Trautman, who wrote the QSR in the 1990s. See what she said here.

"When Melissa [Torres] and the team at FDA take this project on, it's not going to be just about looking at Part 820 [the QSR] by itself. A lot of other regulations will also have to be considered, because there are ties – there are ties in the actual words. There are definite linkages within 820 that tie to other regulations that FDA has that will have to be thought through." –Kim Trautman, executive VP of medical device international services, NSF International

Click here for a free trial of Medtech Insight

Advertisement

Related Content

The QSR/ISO 13485 Maze: How FDA's Satellite Device Rules Will Complicate A Quality System Regulation Rewrite
QSR Author Kim Trautman Predicts What A Mash-Up Of FDA's Quality System Regulation And ISO 13485 Might Look Like

Topics

Advertisement
UsernamePublicRestriction

Register

MT123146

Ask The Analyst

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

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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