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March 2012

eMDR Conversion and Implementation - Part II

by Eugene Reilly
FDA's Center for Devices and Radiological Health

Best practices for submitting eMDRs are similar to those for paper submissions—the more information in the report, the more complete it will be.

And for supplements, we recommend following the instructions found in 21 CFR § 803.56(c), which states that supplemental or follow-up reports should "Include only the new, changed, or corrected information in the appropriate portion(s) of the respective form(s) for reports that cross reference previous reports."

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Betty Lane

Supplier Quality Agreements: Benefits to You and Your Supplier

by Betty Lane
Founder and President, Be Quality Associates, LLC

Supplier quality assurance (QA) agreements can play a vital role in helping companies not only demonstrate to regulatory agencies that they are properly controlling their suppliers, but also show that they are informed and aware of what their suppliers are doing. Manufacturers of all types of medical devices are responsible for the product they make and sell. However, more and more companies are outsourcing all or part of their manufacturing or other operations. Regulatory and certification agencies are therefore looking to the companies that sell the product to have sufficient knowledge and control over their suppliers to assure that products are safe and meet the claims made for them. This article will discuss why supplier agreements are desirable and sometimes even required, which suppliers should have supplier quality agreements, and what should be contained in those agreements.

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Jason Clegg

Effective Nonconformance Management: Key to FDA and ISO Compliance

by Jason Clegg
Marketing Director, MasterControl, Inc.

A product's quality, reliability, and safety depend to a great extent on its conformance to specifications that have been tested, proven safe, and approved. This is particularly critical in products that have direct impact on public health and safety, such as medicines, medical devices, cars, household appliances, and other consumer goods.

For this reason, the proper handling of nonconforming products is incorporated in Food and Drug Administration (FDA) regulations covering drugs, medical devices, and biologics, and ISO international standards, which apply to manufacturers of a wide range of consumer goods.

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Did You Know?

MD&M East
May 21-24, 2012, Philadelphia, PA

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Did you know that the FDA is considering a new, non-binding guidance that would encourage companies to include more women in their medical device clinical trials? "The guidance recommends companies keep enrollment in trials open until enough women have been enrolled to give statistically valid information about the device's efficacy in both men and women."
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