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Requirements Management Plan

This Requirements Management Plan outlines how a project's requirements will be defined, prioritized, traced, and maintained. Key activities include conducting research and interviews to identify requirements, prioritizing them using defined metrics, and ensuring each requirement is designed, implemented, and tested by referencing a Traceability Matrix. The plan defines roles for managing requirements and describes revision procedures to control changes to the document.

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102 views

Requirements Management Plan

This Requirements Management Plan outlines how a project's requirements will be defined, prioritized, traced, and maintained. Key activities include conducting research and interviews to identify requirements, prioritizing them using defined metrics, and ensuring each requirement is designed, implemented, and tested by referencing a Traceability Matrix. The plan defines roles for managing requirements and describes revision procedures to control changes to the document.

Uploaded by

nonolskate
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
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Requirements Management Plan

Project Name: project-name-here


Version: version-here
Author: your-name-here
Last-Revision-Date: MM/DD/YY

Contents
1. Purpose ................................................................................................................................................. 1
2. Definitions, Abbreviations, Acronyms .................................................................................................. 1
3. References ............................................................................................................................................ 1
4. Roles & Responsibilities ........................................................................................................................ 2
5. Planning, Tracking, & Reporting Requirement Activities ...................................................................... 2
6. Defining Requirement Activities ........................................................................................................... 2
7. Prioritizing Requirement Activities & Product Metrics ......................................................................... 2
8. Tracing Requirements Activities ........................................................................................................... 2
9. Revision procedures.............................................................................................................................. 2

1. PURPOSE
[Purpose, introduction, scope of document.]

2. DEFINITIONS, ABBREVIATIONS, ACRONYMS


Term Definition
Application The software component of the system
Software An electronic program consisting of algorithms, control logic, data structures,
data sets, operating system, user interface. Software may consist of critical and
non-critical components and may be used as a part or as an accessory of a
medical device to perform pre-defined and approved operations on medical
devices. Software may itself be a medical device. Software may be used in the
production of a device (e.g. programmable logic controllers used in the
manufacturing of equipment.) Software may be used in implementation of the
device manufacturer’s quality system (e.g. Software that records and maintains
the device history record.
SOP Standard Operating Procedure
[ex.] [these are examples. Remove above, or add below.]

3. REFERENCES
 FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
 Draft Guidance for Industry and Food and Drug Administration Staff Mobile Medical Devices

1
 FDA 21 CFR Part 820 Quality System Regulation
 [above are examples. add or remove as needed. Note: all management plans must reference the
Project Management Plan. Additionally, the Project Management Plan must reference all other
management plans. These references reflect the relationship between the Integration KA and all
other KAs]

4. ROLES & RESPONSIBILITIES

Name Role Responsibilities

5. PLANNING, TRACKING, & REPORTING REQUIREMENT ACTIVITIES


[text-here. How will the PMs maintain requirements to ensure their communicated and stay up to
date?]

6. DEFINING REQUIREMENT ACTIVITIES


[text-here. How will the PMs and analysts identify requirements? This generally involves research,
investigation, and interviews. Formally describe the process.]

7. PRIORITIZING REQUIREMENT ACTIVITIES & PRODUCT METRICS


[text-here. Requirements must be prioritized so that they can be allocated the necessary time and
resources. How will you prioritize your requirements, and using what metrics? (You can’t do everything
under the sun, so you need to prioritize.)]

8. TRACING REQUIREMENTS ACTIVITIES


[text-here. Requirements have to be identified, designed, implemented, then tested (in a nutshell.) How
will you ensure each requirement goes through the necessary processes? Describe the process. It is
essential to mention and reference the Traceability Matrix, it’s role and purpose.]

9. REVISION PROCEDURES
[text-here, describes the procedure that will control revisions to this document. Drafting, reviewing,
approving, releasing, distributing]

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