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Product Risk Management Under ISO 14971:2007
Author: John E. Lincoln

Welcome to “Device Validation Forum.”

This column discusses regulatory requirements, scientific principles, strategies, and approaches associated with medical device validation that are useful to practitioners. While the focus will be on validation issues as they pertain to medical devices, we recognize that many other activities and/or disciplines impact device validation. We intend this column to be a valuable resource for daily work applications. The key objective for this column: Useful information.

The topic of medical device validation is broad and complex. It involves many different products, several industries, and multiple disciplines within the organization. Products involved may range from highly sophisticated electronic devices for internal use to less complex medical instruments. Often products and components from multiple sites around the globe must be coordinated. Adding to this range of devices are combination products that combine drug ingredients to medical devices. These combination devices must then be in compliance with both device and drug regulations.

The production of medical devices involves personnel in product development, equipment design and installation, manufacturing process design and development, software, risk management, analytical method development, manufacturing, testing, quality assurance, distribution, and increasingly, product lifecycle and “green” issues resolution. Each of these areas has different backgrounds, education, perspectives, and standards. Within the organization, they must interact, transfer technology, and discuss common problems. A common understanding of basic principles in medical devices is fundamental to daily manufacturing, CAPA, problem investigations and root cause analysis, and other applications. In addition to the diversity of topics in medical devices, its terminology may be highly technical and often unique to various groups in the organization. And for those not currently involved with devices, consideration of device validation issues can provide a fresh perspective and synergism for problem solving in their organization.

These considerations make discussion of medical device topics a challenging task. This column will address the various topics associated with medical device validation with these considerations in mind. We intend to present these topics in a clear and meaningful way so that our readers in different industries and areas within the organization will be able to understand and apply the principles discussed.

Reader comments, questions, and suggestions are needed to help us fulfill our objective for this column. Please send your comments and suggestions to column coordinator John E. Lincoln at jel@jelincoln.com or to journal coordinating editor Susan Haigney at shaigney@advanstar.com.

KEY POINTS
The following key points are discussed in this article:
• ISO 14971:2007 requires the manufacturer of medical devices to make judgments relating to safety of the medical device, including the acceptability of risks, and provides a format and suggested tools to use in the identification of the hazards
• The risk management process includes the development of a company risk management plan. The risk management plan comprises senior management commitment, high-level strategic considerations, and product level considerations. The risk management process includes risk analysis, purpose, hazards, and risk estimation. These activities are addressed and documented in the risk management file and summarized in the risk management report.
• The risk management file and risk management report should be updated when additional information is noted

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