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

Preparing for UDI in the US: best practices for medtech

This article was originally published in SRA

Executive Summary

As the September 24 deadline approaches for Class III medical device manufacturers to comply with new US requirements for unique device identification requirements, Neil Gleghorn explores the approaches being taken by affected companies and offers some advice.

You may also be interested in...



Complying with new global labeling/traceability rules: piecemeal vs data-centric approach

International regulatory requirements are becoming ever more stringent in the medical device sector, particularly in the areas of labeling and traceability. Neil Gleghorn, CEO of labeling content management specialist Kallik, explains what the changes are and the difference between adopting a data-centric approach to labeling creation versus piecemeal solutions which address UDI traceability in isolation

The regulatory pressures for medical device labelling in established and emerging markets

Neil Gleghorn explains how medical device manufacturers can navigate the new and differing requirements on labelling around the world.

Latest Headlines
See All
UsernamePublicRestriction

Register

MT040340

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