List Of Medical Devices

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Summary

The List of Medical Devices is a comprehensive registry that documents all current and previous versions of your medical device software, including version details, release dates, device identifiers, and market availability. This document serves as a master record for device lifecycle management and provides essential traceability information for regulatory authorities, customers, and internal quality management.

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Why is List of Medical Devices important?

This document provides complete traceability of your device versions throughout the entire product lifecycle, which is essential for regulatory compliance and post-market surveillance. Regulatory authorities require clear documentation of all device versions to track safety performance, manage recalls if necessary, and verify compliance with ongoing regulatory requirements. For manufacturers, this list enables systematic version management, helps identify which versions are still supported in the market, and provides critical information for customer support and technical assistance.

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Regulatory Context

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Guide

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Current Device Information Management

Maintain accurate information about your current device version including the exact device name, current software version, release date, UDI-DI, and complete market availability information. This section should always reflect the most recent version available to customers and must be updated with each new release. Ensure consistency between this information and your device registration databases, technical documentation, and marketing materials.

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Version History Documentation

Document all previous software versions with complete details including version numbers, release dates, decommissioning dates when applicable, and associated device identifiers. This historical record is crucial for traceability, customer support, and regulatory compliance. Include information about when older versions were withdrawn from the market and any transition periods where multiple versions were simultaneously available.

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Market Availability Tracking

Clearly document which markets and countries your device is available in for each version. This information is essential for regulatory compliance, as different markets may have different approval timelines and requirements. Update this information when you gain market access in new countries or when regulatory status changes in existing markets. Consider including specific regulatory approval dates for major markets.

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Device Identifier Management

Maintain accurate UDI-DI information for each device version, ensuring consistency with regulatory databases and labeling. Each software version may have a different UDI-PI while sharing the same UDI-DI, so document these relationships clearly. This information is critical for regulatory traceability and post-market surveillance activities.

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Similar Device Documentation

Include information about similar marketed devices that may be relevant for regulatory comparison, competitive analysis, or clinical evaluation purposes. This can include predicate devices used for FDA submissions, similar devices in your product portfolio, or competitor devices that serve similar clinical purposes. This information supports regulatory strategy and market positioning.

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Lifecycle Status Management

Track the lifecycle status of each device version including active, deprecated, or decommissioned status. Document support timelines, end-of-life dates, and migration paths for customers using older versions. This information helps manage customer relationships and ensures appropriate support for devices still in clinical use.

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Integration with Quality Management

Ensure your device list integrates with your quality management system and change control processes. Each new version should be added through your established change control procedures, and the list should be updated as part of your software release process. This ensures consistency between your device registry and other quality documentation.

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Example

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Scenario

You are maintaining the device list for your telemedicine platform that provides remote patient monitoring and consultation services. The platform has evolved through several versions with different feature sets and market availability, and you need to track all versions for regulatory compliance and customer support.

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Example List of Medical Devices

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1. Scope

This document describes the latest device details and as well as details for previous device versions for TeleCare Pro remote patient monitoring platform.

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2. Current Medical Devices

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3. Previous Versions

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4. Similar Devices

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Q&A