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The Economics of a Sound Regulatory Strategy
While it might be tempting to put off regulatory requirements on a new project, a regulatory assessment should be performed fairly early.Christine Scifert and Dawn Norman, M.S., MRC-X LLC 04.01.20
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Software & IT
Five Strategies to Navigate Regulatory Challenges in Medical Device Development
...Seth J. Goldenberg, Ph.D., Vice President, Vault Medical Device & Diagnostics, Veeva Systems 07.30.19
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Software & IT
Hand-in-Hand with Quality and (Regulatory) Changes
Greenlight Guru’s founder speaks with MPO about the firm’s FDA-connected initiatives and the changing regulatory landscape.Online Exclusives Sean Fenske, Editor-in-Chief 04.03.19
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Professional Development for the Quality/Regulatory Professional
...James A. Dunning, Principal, QPC Services LLC 10.16.18
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Digital Health
Mobile Medical Applications: The Regulatory Framework in the U.S. and the EU
...Sudeep Kolluri, Solutioning Lead, Freyr 06.04.18
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Software & IT
How an Automated QMS Helps to Keep Up with Regulatory Changes
...Alexa Sussman, Content Marketing Writer, EtQ 03.15.18
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Mike on Medtech: Quality vs. Regulatory
Mike Drues and Sean Fenske discuss these interrelated terms and their relevance to the industry, while offering examples.Sean Fenske, Editor-in-Chief 03.02.18
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Cardiovascular | Contract Manufacturing | R&D & Design | Testing
The New Role of Regulatory Affairs in Medical Device Manufacturing
Today’s market realities have reshaped the role of regulatory affairs within the medical device development process. But are companies keeping pace?Kellen Hills, Contributing Writer 11.13.14
