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. June 14, 2018. Phil Pontikos.

Executive Summary

US FDA is concerned about the large number of recalls initiated by device-makers and is urging firms to take a close look at their quality systems to determine why troublesome products make it to market in the first place. See what the agency's national device expert, Phil Pontikos, said about it here.

"From our perspective, what we see is that firms can identify the cause – or causes – of a failure, and then engage in CAPA [corrective and preventive action] activities. But firms also need to ask themselves a big question: 'Why did the quality system that we put in place fail us so we couldn't figure [the problem] out before we released it?'" –Phil Pontikos, national device expert, US FDA

Click here for a free trial of Medtech Insight

Advertisement

Related Content

As Device Recalls Hit The Stratosphere, FDA Asks Firms To Keep A Sharp Eye On Quality Systems

Topics

Advertisement
UsernamePublicRestriction

Register

MT122829

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