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The Impact of Change on Regulatory Compliance
It’s that time of year again. Time for a calendar change. Out with the old and in with the new. Time for another 12-month journey into the unknown. It’s also time for new beginnings—a period that can be simultaneously fun, exh…James A. Dunning, Principal, QPC Services LLC 01.30.19
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Taking Stock of MDR Compliance
Just over a year in since the new regulations were rolled out and companies are lagging well behind in meeting them.Online Exclusives Peter Rose, Managing Director—Europe, Maetrics 08.23.18
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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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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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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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Compliance and Quality Part 2—Food for Thought
What do life science companies and restaurants have in common?Infographics Axendia
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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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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 | R&D & Design
First Steps in a CE Marking Compliance Strategy
The second article in this series seeks to advise on a strategy to address European regulatory requirements.Online Exclusives Bernard Tremaine, Owner, MDRS UK 03.01.16
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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
