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

Draft Revision Of Risk Management Standard Gives Firms More Guidance

This article was originally published in The Silver Sheet

Executive Summary

MANAGERS AND EMPLOYEES RESPONSIBLE FOR RISK MANAGEMENT will soon gain updated guidance, thanks to a revision of ISO 14971, the voluntary international standard that explains how to manage medical device risk. While the changes offer new insights for all companies, manufacturers of in vitro diagnostic devices could benefit most from the expanded standard, says FDA’s Bill Midgette... TRENDS FACING THE DEVICE INDUSTRY IN 2007 include greater FDA enforcement of outsourcing controls and a continued focus on postmarket issues, experts predict...
Advertisement

Related Content

Benefit-Risk Is Front-And-Center In Latest Revision Of International Risk Management Standard ISO 14971

Topics

Advertisement
UsernamePublicRestriction

Register

MT036117

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