Software Requirements Analysis Template

The purpose of Software Requirements Analysis is to describe the software requirements for the system/device.

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Key Standards & Guidance

All of our premium templates satisfy FDA standards and requirements

21 Code of Federal Regulations – Part 11 Electronic Records; Electronic Signatures
21 Code of Federal Regulations – Part 820 Quality System Regulation for Medical Devices and In Vitro Diagnostic Products
AAMI TIR45:2012 - Guidance on the Use of AGILE Practices in the Development of Medical Device Software
AAMI/ISO 80002-2:2017 - Medical device software— Part 2: Validation of software for medical device quality systems
AAMI/ISO TIR24971:2020 - Medical devices — Guidance on the application of ISO 14971
ANSI/AAMI HE75:2009 (R2018) Human Factors Engineering - Design Of Medical Devices
FDA Content of Premarket Submissions for Software Contained in Medical Devices
FDA Design Controls Guidance for Medical Device Manufacturers

FDA General Principles of Software Validation
FDA Guidance Applying Human Factors and Usability Engineering to Medical Devices
FDA Off-The-Shelf Software Use in Medical Devices
IEC 60601-1 Medical electrical equipment
IEC 62304 – Medical Device Software – Software Life Cycle Processes
IEC 62366-1:2015 Medical Devices - Part 1: Application Of Usability Engineering To Medical Devices
IEC 82304 – Health Software - Part 1: General requirements for product safety
IEC/TR 80002-1:2009 - Medical device software – Part 1: Guidance on the application of ISO 14971 to medical device software

IEC/TR 80002-3:2014 - Medical device software -- Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
IEEE 610.12-1990 - IEEE Standard Glossary of Software Engineering Terminology
ISO 9001:2015 Quality management systems — Requirements
ISO 13485:2016 Medical Devices – Quality Management Systems
ISO 14971:2019 - Medical devices – Application of risk management to medical devices
ISO/IEC/IEEE 29148-2018 - Systems and software engineering -- Life cycle processes -- Requirements engineering
REGULATION (EU) 2017/745 – Medical Device Regulation
REGULATION (EU) 2017/746 – In Vitro Diagnostic Regulation