Medical Device Product Requirements Document

Company: [YOUR COMPANY NAME]

Address: [YOUR COMPANY ADDRESS]

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I. Introduction

a. Purpose:

This document outlines the requirements for the development of a Heart Monitoring Medical Device.

b. Scope:

The requirements specified in this document apply to the development team responsible for designing and developing the Heart Monitoring Medical Device.

c. Audience:

This document is intended for use by the development team, including engineers, designers, and other stakeholders involved in the project.

II. Product Overview

a. Description:

The Heart Monitoring Medical Device is a portable device designed to monitor and record a patient's heart activity.

b. Key Features:

• Continuous monitoring of heart rate and rhythm.

• Real-time data display and recording.

• Alarm system for abnormal heart activity detection.

• Long battery life for extended monitoring periods.

• Compatibility with mobile devices for data transfer and analysis.

III. Functional Requirements

• User Requirements: The device should be easy to use for both healthcare professionals and patients.

• System Requirements: The device should have a compact design with minimal weight for portability.

• Performance Requirements: The device should provide accurate heart rate and rhythm monitoring with a minimal margin of error.

• Safety Requirements: The device should have built-in safety features to prevent overheating and electrical hazards.

• Reliability Requirements: The device should be reliable under various environmental conditions and usage scenarios.

IV. Design Requirements

• Design Constraints: The device design should comply with relevant regulatory standards, such as FDA regulations for medical devices.

• Design Specifications: The device should be designed with durable materials that can withstand daily use and potential impacts.

V. Regulatory Requirements

• Regulatory Standards: The device should comply with FDA regulations for medical devices, including standards for safety and performance.

• Compliance Plan: A plan should be in place to ensure that the device meets all regulatory requirements before market release.

VI. Testing Requirements

• Test Plan: A comprehensive test plan should be developed to validate the device's performance and safety.

• Verification and Validation: The device should undergo rigorous verification and validation testing to ensure it meets all specified requirements.

VII. Documentation Requirements

• User Manuals: The device should come with user manuals that provide clear instructions for use and maintenance.

• Labeling Requirements: The device labeling should comply with regulatory requirements and provide essential information about the device.

VIII. Project Timeline

a. Development Phases:

1. Design Phase (Month 1-2): Develop initial design concepts and select components.

2. Prototyping Phase (Month 3-4): Build and test prototypes for functionality and performance.

3. Testing Phase (Month 5-6): Conduct thorough testing to ensure accuracy and reliability.

4. Production Phase (Month 7-8): Prepare for mass production and quality control.

b. Milestones:

• Design Approval (End of Month 2): Finalize design concept and component selection.

• Prototype Testing Complete (End of Month 4): Verify prototype functionality and performance.

• Regulatory Approval (End of Month 6): Obtain FDA approval for the device.

• Production Ready (End of Month 8): Begin mass production of the device.

IX. Budget

This is the estimated development costs for the Heart Monitoring Medical Device:

• Design and Development: $100,000

• Prototyping: $50,000

• Testing: $30,000

• Regulatory Compliance: $20,000

  Total: $200,000

X. Approval

Prepared and approved by:

[YOUR NAME]

Senior Product Manager

XI. Appendices

• Reference materials on heart monitoring technologies.

• Contact information for regulatory authorities.

• Design specifications and schematics for the device.

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