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


Companies With Quality Systems Troubles Can Get On Road To Better Compliance With ASC Pilot

The new FDA/MDIC pilot program is modeled after the popular Case For Quality Voluntary Improvement Program

Executive Summary

Calling all manufacturers with spotty quality systems compliance histories or US FDA warning letters on their desk: The agency wants you for a new pilot program it’s coordinating with the Medical Device Innovation Consortium. The Accelerate Sustainable Capability (ASC) pilot aims to boost manufacturing and process quality, as well as improve compliance at underwhelming firms.


Latest Headlines
See All



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