Standards and Compliance

The U.S. Food and Drug Administration (FDA) has issued a guidance document for medical...

Is your test software the goose that has laid its golden eggs or is your software misbehaving? Does it run amok? The purpose of this article is to provide an understanding of the software validation requirements, the validation rationale, and suggest independent tools that will allow you to develop your own test software validation process.

This article explains the development process of a proficiency testing programme that is suitable for electrical and mechanical safety tests. The process for testing the homogeneity and stability of specimens is also discussed.

The way you market your product can turn an otherwise safely designed product into an unsafe product that causes injury and creates liability for the manufacturer and product seller.

The International Medical Device Regulators Forum (IMDRF) has reportedly proposed an update to its...

This article discusses the IEC 60601 Amendments Project, for Medical Electrical Safety, some of the changes to the General and Collateral Standards of the Project, and their impact on manufacturers. The future of the 60601 series of standards is also discussed.

This article discusses additional requirements that designers and safety professionals may want to consider beyond the base standard for their product based on the environment and user exposure.

This new international specification focuses on workplace safety sign systems. Yet many of its underlying concepts speak to various forms of safety communication meant to reduce risk in today’s world – including product safety labeling.

The U.S. Food and Drug Administration (FDA) is requesting input on a planned web-based...

The U.S. Food and Drug Administration (FDA) has issued a guidance document on the...