August 2013

For Medical Device Companies

Elements of Effective Quality Agreements

by: Steven Sharf, GMP Concepts

Many GxP professionals are already familiar with the expectation of FDA and the requirement in the EU to have quality agreements with third parties and suppliers. Throughout this article, I will define what a quality agreement is, when one is needed, the 24 basics that factor into this critical document, and some things to avoid when drafting one. Finally, I will discuss alternate means of communicating quality expectations when a supplier will not agree to enter into a full quality agreement.

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Building a Quality Plan for Implementing EN ISO 14971:2012

by: Robert Packard,

Rob Packard reviews the seven deviations in Annex ZA, ZB, and ZC with respect to the intent of the Medical Devices Directorate (MDD), the AIMD, and the In Vitro Diagnostic Directive(IVDD).

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Avoiding Human Error in Design

by: BW (Ben) Marguglio, BW Marguglio, LLC

Any enterprise that is engaged in activities with the potential for public and employee harm should be encouraged, if not required to develop and implement an integrated risk management, safety management, quality management and environmental management system for the prevention of events with intolerable effects. Such a management system would establish various techniques by which to analyze the safety and quality of the designs of hardware and processes.

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Coming Soon:

In the September issue of GxP Lifeline, look for Rob Packard’s article on how to prepare your DHF for the FDA.  If you don’t know what a DHF is, this article is for you!

Greg Hutchins defines risk, outlines the parallels between risk and quality, and explains risk management in “Must Know Risk Facts for Quality and All Professionals.”

If you’ve ever wondered what the buzz about “the cloud” really means, don’t miss Victor Gill’s article on cloud basics.  He’ll explain the basics of cloud computing so you can really understand the subject. Cloud computing is having a major impact on the medical device industry.

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