This article presents a strategy that benefits medical device manufacturers who initiate risk management early in the product development lifecycle. A risk management program compliant to the latest revisions of ISO14971, can support design, verification, validation efforts, improve post-market planning, and simplify regulatory compliance. Find out how.

This article describes strategies to ensure reliability in new products, and describes how and why to consider reliability engineering early in the technology development cycle.

This article presents a strategy that medical device manufacturers can use to assess, analyze, and control risks related to the use of medical devices, compliant to the latest revisions of ISO14971.

This article describes some of the challenges faced when using failure rate databases for reliability assessment and prediction in the development of new products. Applicable to any industry.