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

Miles To Go? Case For Quality Founding Father Silverman Says Joint FDA/MDIC Initiative Isn't 'Where It Should Be'

Executive Summary

Steve Silverman – one of the original architects of the popular Case for Quality when it was launched by US FDA in 2010 – is disappointed that the initiative hasn't come further over the past eight years. "I don’t think that the Case for Quality is where it should be," Silverman, who currently is AdvaMed's VP of technology and regulatory affairs, said at a Case for Quality open forum. His blunt words came despite the momentum building behind several ongoing Case for Quality projects, including a pilot program to assess device-makers' manufacturing maturity and capability.

Advertisement

Related Content

Boston Scientific, Edwards Lifesciences, Baxter Used CMMI To Measure Their Manufacturing Capability. Here's What They Said About The Experience
Device-Makers Like Baxter Are Lining Up To Let CMMI Evaluate Their Manufacturing Site Capabilities. Here's What To Expect If You're Appraised
Chasing Quality Isn't Easy. But An FDA Pilot Aims To Boost Quality By Appraising The Capability Of Manufacturing Sites
Metrics 'Best Practices' Laid Bare In New Guide That Helps Drive Manufacturers Toward Gold-Star Device Quality
At The Intersection Of Quality And Metrics: What's Ahead In FDA’s Effort To More Objectively Measure Quality
Industry Globalization Behind New FDA Device Center Quality Initiative

Topics

Related Companies

Advertisement
UsernamePublicRestriction

Register

MT122992

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