Search Results for 'compliance'

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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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  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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• Electronics | Software & IT | Testing
  

  EMC and Wireless Compliance of Active Implantable Medical Devices

  It is imperative to ensure AIMDs' safety and performance regarding EMC and wireless coexistence.

  Online Exclusives Minal Shah, Sr. Project Engineer, Intertek 10.29.18
  

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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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• 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
  

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