ISO TR 80002-2:2017
Medical device software - Part 2: Validation of software for medical device quality systems
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About This Item
ISO TR 80002-2:2017 is a technical reference for Medical device software - Part 2: Validation of software for medical device quality systems, supporting organizations that need to assess software used within quality-related processes. It is relevant when engineering, testing, and compliance teams must document how software is evaluated, controlled, and validated as part of regulated workflows. For procurement and technical review, ISO TR 80002-2:2017 helps identify whether a software-related quality system approach is aligned with validation expectations and risk management practices.
What is ISO TR 80002-2:2017?
This technical report addresses validation of software used in medical device quality systems, with emphasis on how such software is reviewed and controlled within a quality management context. It is best understood as a practical compliance reference for documented evaluation, verification activities, and technical assessment rather than a product specification. Organizations may use it to support internal procedures, define validation evidence, and structure engineering documentation around software that affects quality workflows and regulatory preparation.
Applications of ISO TR 80002-2:2017
ISO TR 80002-2:2017 is commonly relevant to teams managing quality system software in medical device organizations, including document control, change management, complaint handling, audit support, and other operational consistency functions. It may also be used by laboratories, validation groups, and compliance teams that need a clear basis for technical validation planning and review. In procurement and supplier assessment, it can help clarify what evidence should be requested when software is part of a regulated quality environment.
Why is ISO TR 80002-2:2017 important?
This document matters because software used in quality systems can affect safety, traceability, and conformity assessment outcomes. A structured validation approach helps reduce risk, improve testing consistency, and support defensible engineering decisions during technical review. For organizations preparing for audits or regulatory submission support, ISO TR 80002-2:2017 can provide a useful framework for documentation, controlled evaluation, and quality assurance of software-enabled processes.
- Supports validation planning for software used in medical device quality systems
- Helps define documented evidence for technical review and verification activities
- Useful for procurement teams evaluating compliance references and supplier documentation
- Assists with risk management, traceability, and quality workflow control
- Provides a practical basis for regulatory preparation and conformity assessment support
- Publication Date: 2017-06-13
- Standard Status: Original
- Publisher: IEC
- Edition: 1
- This Version: ISO TR 80002-2:2017 (2017-06-13)
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