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CAPA’s Impact on Compliance
You might be wondering why I’m writing about Corrective and Preventive Action (CAPA) in a regulatory column. What else, after all, can be said about CAPA that hasn’t already been articulated? Not much, but there is one thing: how importan…James A. Dunning, Principal, QPC Services LLC 04.03.19
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Selling Regulatory Compliance
Does the title of this column strike a nerve? Does it seem crass or disrespectful to combine “selling” with “regulatory compliance”? I ask these rhetorical questions because I have found that many regulatory professionals feel…James A. Dunning, Principal, QPC Services LLC 07.26.18
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Packaging & Sterilization | Surgical
FDA Warns Duodenoscope Makers About Compliance Failures
Olympus, Fujifilm, and Pentax did not comply with required postmarket surveillance studies to assess contamination risk.U.S. Food and Drug Administration 03.09.18
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The (Capital) Rewards of MDR Compliance
Data shows a $16.5 billion market advantage for medtech firms that comply with the new European Medical Device Regulation.Maetrics 01.04.18
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Materials | Packaging & Sterilization | R&D & Design | Software & IT | Testing
5 Considerations to Ensure UDI Compliance
With another deadline just around the corner, device makers need to review their UDI strategy.Online Exclusives Steve Cottrell, President, Maetrics; Madris Tomes, CEO, Device Events 09.16.16
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Contract Manufacturing | Software & IT
Tools for Maintaining an Audit-Ready State to Ensure Compliance
In the last three years, the U.S. Food and Drug Administration (FDA) issued more than 30 warning letters and 483 form inspectional observations related to electronic records. It appears the medtech industry is not sure how to comply with FDA inspecti…Emily Ysaguirre, VERSE Solutions 06.09.16
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Contract Manufacturing | R&D & Design
Can You Sell Poor Quality Devices in Compliance with Regulations?
An examination of the often-misunderstood relationship between quality and compliance.Online Exclusives Daniel R. Matlis, President, Axendia Inc. 04.11.16
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Compliance and Quality Part 1—Following the Rules Isn't Enough to Win
In the game of compliance versus quality, avoiding penalties doesn't ensure success.Infographics Axendia
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Contract Manufacturing
The Role of Risk Management in Compliance: Tools for Success
Organizations today are more complex—businesses are increasing their global footprint with a worldwide scope of locations around the world. This, coupled with the addition of mergers and acquisitions, results in disparate trends in compliance.…Alexandre Alain, Life Science Product Manager, EtQ Inc. 03.10.16
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Contract Manufacturing | Software & IT
Global Harmonization: The Key to Compliance that Spans the Supply Chain
Business today has become increasingly global in nature. Life science organizations in particular often extend manufacturing to suppliers who are located around the world. For suppliers to effectively operate within this global environment, a harmoni…Brenda Percy, Content Editor, EtQ Inc. 02.03.16
