Fundamentals of medical device process validation for molded rubber and other parts

This white paper explores how, when carefully planned and properly performed, process validation can improve overall quality, reduce cost and scrap, increase customer satisfaction and decrease time to market. The white paper also provides information on several key process validation topics that help ensure products can be manufactured as designed to meet user needs and intended uses. Topics include design validation; molded-rubber component process validation; and first article inspection (FAI). It also provides information on the validation report with summary data, which includes evidence of all results meeting the validation requirements.

“Having a basic knowledge of the approach manufacturers use to develop and maintain process validation can help companies take advantage of additional benefits,” says Mark Erson, director of quality assurance at Precision Associates, Inc.

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