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Summary

Release Notes document the changes, improvements, and bug fixes implemented in each version of your medical device software. This document provides users, regulatory authorities, and internal teams with clear information about what has changed between software versions and serves as a critical component of your software lifecycle documentation.

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Why is Release Notes important?

Release Notes serve as transparent communication about software changes to all stakeholders including healthcare providers, patients, and regulatory authorities. They provide essential traceability for software modifications and demonstrate systematic change management required by medical device regulations. For healthcare users, release notes help them understand new functionality, safety improvements, and any workflow changes that may affect patient care. Regulatory authorities use release notes to assess the impact of software changes and verify compliance with post-market surveillance requirements.

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Regulatory Context

Under 21 CFR Part 820 (Quality System Regulation):
  • Change control (820.40) requires documentation of all design changes
  • Design history file (820.30) must include records of design changes
  • Software validation guidance requires documentation of software modifications
  • Labeling controls (820.120) apply to software version identification
Special attention required for:
  • Documentation of cybersecurity-related changes and improvements
  • Clear identification of changes that affect substantial equivalence
  • Integration with post-market surveillance reporting requirements
  • Version control alignment with FDA software guidance documents

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Guide

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Version Identification and Dating

Each release notes document must clearly identify the specific software version and release date. Use your established version numbering scheme from your Software Development and Maintenance Plan to ensure consistency across all documentation. The release date should reflect when the software version was made available to users, not when the release notes were written. This information is critical for traceability and regulatory compliance.

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Change Documentation Structure

Organize your release notes into clear categories that help users understand the nature and impact of changes. Typically include sections for new features or enhancements, bug fixes, security improvements, and any known limitations or issues. Each change should be described in user-friendly language that healthcare professionals can understand, avoiding technical jargon when possible while maintaining accuracy.

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Feature and Enhancement Documentation

When documenting new features or enhancements, focus on the clinical benefit and user impact rather than technical implementation details. Describe how the changes improve patient care, workflow efficiency, or safety. Include any new user interface elements, workflow changes, or performance improvements that users will notice. This helps healthcare providers understand how to leverage new capabilities effectively.

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Bug Fix Documentation

Document all safety-relevant bug fixes and significant functional corrections. While you don’t need to list every minor bug fix, include those that could affect clinical decision-making, patient safety, or workflow reliability. Describe the issue that was resolved and the improvement users can expect. This transparency builds trust and helps users understand the ongoing quality improvements.

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Security and Performance Updates

Clearly document any cybersecurity improvements or performance enhancements, as these are increasingly important for medical device software. Describe security patches, encryption improvements, or access control enhancements in terms that help users understand the safety benefits. Performance improvements should be quantified when possible to help users understand the practical impact.

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User Communication Considerations

Write release notes for your primary users - healthcare professionals who may not have technical backgrounds. Use clear, concise language and focus on practical implications rather than technical details. Consider including guidance on any workflow changes or new training requirements that may result from the software updates.

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Example

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Scenario

You are releasing version 3.2.1 of your patient monitoring software that includes enhanced alarm algorithms, improved data visualization, and several critical bug fixes. The software is used in intensive care units to monitor patient vital signs and alert healthcare staff to critical changes.

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Example Release Notes Document

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Release Notes - CardioWatch Pro - Version 3.2.1

Date: April 22, 2024 Version: 3.2.1

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Changes

Enhanced Alarm Intelligence
  • Implemented advanced machine learning algorithms to reduce false alarms by 35% while maintaining 100% sensitivity for critical events
  • Added contextual alarm prioritization that considers patient history and current clinical status
  • Introduced smart alarm clustering to prevent alarm fatigue during multi-parameter events
  • Enhanced arrhythmia detection with improved specificity for atrial fibrillation and ventricular tachycardia
Improved Data Visualization
  • Redesigned trend display with customizable time scales (1-hour to 7-day views)
  • Added color-coded severity indicators for all monitored parameters
  • Implemented high-contrast mode for improved visibility in low-light environments
  • Enhanced touch interface responsiveness for tablet-based monitoring stations
Workflow Enhancements
  • Added quick-access buttons for common clinical scenarios (post-operative, cardiac care, respiratory distress)
  • Implemented automatic parameter adjustment based on patient age and condition
  • Enhanced report generation with customizable templates for different clinical specialties
  • Added integration with hospital information systems for automatic patient data synchronization

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Bug Fixes

Critical Fixes
  • Resolved intermittent alarm delay issue that could cause up to 3-second delays in critical alarm notifications
  • Fixed data synchronization error that occasionally caused patient parameter history to display incorrectly
  • Corrected calculation error in mean arterial pressure that affected readings above 150 mmHg
  • Resolved network connectivity issue that could cause temporary data loss during WiFi handoffs
Functional Improvements
  • Fixed user interface freezing issue when accessing patient history during high network traffic
  • Corrected timestamp accuracy for alarm logs to ensure precise event documentation
  • Resolved printing issues with trend reports on certain network printer models
  • Fixed minor display artifacts in waveform rendering during screen rotation
Security Updates
  • Enhanced encryption protocols for patient data transmission
  • Implemented additional access controls for administrative functions
  • Updated authentication mechanisms to prevent unauthorized device access
  • Strengthened audit logging for all user interactions and system events

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Q&A