Medtech Insight is part 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. 4 February 2020. Kim Trautman.

Executive Summary

The new US-Mexico-Canada (USMCA) free-trade agreement aims to make it easier for the three countries to align on inspecting medical device manufacturing facilities by using the Medical Device Single Audit Program (MDSAP). Former US FDA official Kim Trautman explains how Mexico – which currently doesn’t accept the results of MDSAP audits – can come up-to-speed with the program.

“There are different ways that [Mexico] has available to become familiar with the MDSAP audits and program requirements for them to gain the assurances they need to understand how best they might use MDSAP in their regulatory framework.” – Kim Trautman, executive VP of health sciences, NSF International

Click here for a free trial of Medtech Insight

 

Related Content

Topics

UsernamePublicRestriction

Register

MT126201

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