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

Compliance Corner: Design Creep Can Turn Your Model T Into The Batmobile, FDA Investigator Warns

Executive Summary

Intertwining design changes and document control is vital for manufacturers – especially for those whose creeping changes to a medical device can turn it into an altogether different product that requires a new 510(k) or PMA from the US FDA. Longtime agency investigator Laureen Geniusz weighs in on what she has seen in the field and offers other nuggets of design change advice.

Advertisement

Topics

Advertisement
UsernamePublicRestriction

Register

MT125259

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