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Article: Recipe for risk management: using automated process software in the design, manufacture, and quality control of your device implies that you should validate it to he FDA compliant. This exclusive report shows how this can be done and examines the steps necessary to accomplish it--the analyses, tests, meetings, and documentation.(Cover Story)
- Article from:
- Medical Design Technology
- Article date:
- February 1, 2005
- Author:
CopyrightCOPYRIGHT 2005 Advantage Business Media. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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Manufacturers of medical devices are required by federal law to validate software that is part of the manufacturing or quality system. But there is confusion about what this means. What software does the FDA regulate? What level of validation is required?
There are no checklists available from the FDA. However, an Association for the Advancement of Medical Instrumentation (AAMI) workgroup has been formed to write a technical information report on the topic of software validation for regulated automated process software. This AAMI report will address in detail some of the issues that are discussed here in a simplified form. Meanwhile, there is good documentation ...