Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

QMSR Quick Take: QSR Author Kim Trautman

Executive Summary

Former US FDA official and longtime industry expert Kim Trautman gives a quick take on the agency’s proposed Quality Management System Regulation. The QMSR would replace the FDA’s current Quality System Regulation, which Trautman lead authored in the 1990s.

You may also be interested in...



QMSR Quick Take: Medtech Consultant Steve Silverman

Steve Silverman, a former compliance director for the US FDA’s device center, gives a quick take on the agency’s proposed Quality Management System Regulation. The QMSR would replace the FDA’s current Quality System Regulation.

QMSR Quick Take: Attorney Dennis Gucciardo

Morgan Lewis partner Dennis Gucciardo gives a quick take on the US FDA’s proposed Quality Management System Regulation. The QMSR would replace the agency’s current Quality System Regulation.

QMSR Quick Take: Quality Expert Eric Henry

Eric Henry, senior quality & regulatory compliance advisor at the law firm King & Spalding, gives a quick take on the US FDA’s proposed Quality Management System Regulation. The QMSR would replace the agency’s current Quality System Regulation.

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT145105

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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