ISO/IEC/IEEE 15289

ISO/IEC/IEEE 15289: Clarity at Last for Software Documentation? The title of ISO/IEC/IEEE 15289 is “Systems and software engineering — Content of life-cycle information items (documentation)”. As the title suggests, it establishes specifications for the content of...

Third edition of ISO 14971

Third edition of ISO 14971 – What has changed? The third edition of ISO 14971 is now available as a draft (FDIS). This new version of ISO 14971 will probably be published as ISO 14971:2019. It will represent an evolutionary development of ISO 14971:2007, rather...

Risk Acceptance

Risk Assessment, Risk Acceptance Matrix Each medical device comes with risks. Manufacturers must determine which risks they deem acceptable and which unacceptable. This is usually expressed in the form of a matrix of risk acceptance (or risk assessment matrix). In...

Hazard and Hazardous Situation

Hazard and Hazardous Situation Even though the ISO 14971 defines the terms hazard and hazardous situation, it is still often not so easy for medical products manufacturers to differentiate these two terms. This article will help understand these terms clearly....

Harm and Severity

Harm and Severity The severity of damage in accordance with ISO 14971 The ISO 14971, the standard for risk management for medical devices, defines the term severity (damage) as a “measure of the potential impact of a hazard”. Quantify and classify the...

Update 14971:2012

EN ISO 14971:2012 and the Z-annexes EN ISO 14971: 2012: What has been changed to the standard Virtually overnight, namely from 31.08.2012 to 01.09.2012 the ISO 14971: 2012 was published without a transition period as a harmonized standard for risk management for...