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Software Architecture

Use this Software Architecture template to document the structural design and interconnections of your medical device software in compliance with IEC 62304. You should complete this template during the design and development phase to clearly define software items, their relationships, security measures, and system requirements, ensuring alignment with regulatory expectations and facilitating clear communication among development and regulatory teams. This document is essential for traceability, risk management, and future modifications or audits.
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                 Software Architecture

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1. Scope

This document defines the software architecture according to IEC 62304:2006 as a result of the software and system requirements of Sed ut perspiciatis unde omnis iste natus error sit voluptatem accusantium doloremque laudantium. The software architecture will describe the software's structure and identify the software items. The software architecture will define the interconnectivity between software items within the software system to inform the resources required for developing the software and the potential software units required.

2. Document References

  • SOP Software Development
  • User Needs List
  • Subsystem Requirements List
  • SOUP List

3. Description

The software system is defined by IEC 62304:2006 as the integrated collection of software items organized to accomplish a specific function or set of functions wherein a software item is any identifiable part of a computer program.

Three terms identify the software decomposition. The top level is the software system. The lowest level that is not further decomposed is the software unit. All levels of composition, including the top and bottom levels, can be called software. A software system, then, is composed of one or more software items, and each software item is composed of one or more software units or decomposable software items.

4. Software Architecture

4.1 Software Item Descriptions

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4.2 Software Connections

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4.3 Architecture Diagram

A simple diagram of the software architecture, the software items, and their interconnectivity is provided below.

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5. Data Security and Backup

5.1 Encryption and Data Security

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5.2 Backup Procedures

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6. Minimum User System Requirement

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