System Architecture Description of XXX

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 System Architecture Description of XXX

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TABLE OF CONTENTS
1 Introduction 2
1.1 Document overview 2
1.2 Abbreviations and Glossary 2
1.2.1 Abbreviations 2
1.2.2 Glossary 2
1.3 References 2
1.3.1 Project References 2
1.3.2 Standard and regulatory References 2
1.4 Conventions 2
2 Architecture 3
2.1 Architecture overview 3
2.2 Logical architecture overview 3
2.2.1 Software Component 1 description 3
2.2.2 Software Component 2 description 3
2.2.3 Software Component 3 description 3
2.3 Physical architecture overview 3
2.3.1 Hardware Component 1 description 3
2.3.2 Hardware Component 2 description 4
2.3.3 Hardware Component 3 description 4
2.4 Software COTS 4
3 Dynamic behaviour of architecture 5
3.1 Workflow / Sequence 1 5
3.2 Workflow / Sequence 2 5
4 Justification of architecture 6
4.1 System architecture capabilities 6
4.2 Network architecture capabilities 6
4.3 Risk analysis outputs 6
4.4 Human factors engineering outputs 6
5 Requirements traceability 7

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 System Architecture Description of XXX

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1 Introduction

1.1 Document overview

This document describes the architecture of XXX system.
It describes:
 A general description of the system
 The logical architecture of software, the layers and top-level components
 The physical architecture of the hardware on which runs the software
 The justification of technical choices made
 The traceability between the architecture and the system requirements.

1.2 Abbreviations and Glossary

1.2.1 Abbreviations
Add here abbreviations
COTS: Components Off the Shelf (software industry acronym)
OTSS: Off The Shelf Software (FDA acronym)
SOUP: Software Of Unknown Provenance (IEC 62304 acronym)

1.2.2 Glossary
Add here words definitions

1.3 References

1.3.1 Project References

# Document Identifier Document Title

[R1] ID Add your documents references.
One line per document

1.3.2 Standard and regulatory References

# Document Identifier Document Title

[STD1] Add your documents references.
One line per document

1.4 Conventions
Add here conventions
For example for diagrams.

COTS, OTSS and SOUP refer to the same concept, i.e. software delivered by 3 rd party that wasn’t
developed with a regulatory and/or normative compliant development process.
We deliberately use the term “SOUP”, to focus on IEC 62304 compliance.

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 System Architecture Description of XXX

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2 Architecture

2.1 Architecture overview

Give a general description of the system, from the point of view of the user:
• In what environment it works (home, near patient bed, operating room …)
• Who the users are
• What it is for,
• The main functions,
• The main interfaces, inputs and outputs.

If your software is integrated in a larger system, you may reference a document that describes
this system.

2.2 Physical architecture overview

Describe the hardware components on which software runs and their interactions/relationships
Use components diagrams, deployment diagrams, network diagrams, interface diagrams…

2.2.1 Hardware Component 1 description

Describe the content of each hardware component in the architecture
Optional, you may not do it if your software is not class C according to IEC 62304
The description shall contain:
• Its identification
• The purpose of the component
• The software component it receives
• Its technical characteristics: type of machine, CPU, RAM, disk and so on.
• Its network hardware interfaces

2.2.2 Hardware Component 2 description

Repeat the pattern for each top-level component.

2.2.3 Hardware Component 3 description

Repeat the pattern for each top-level component.

2.3 Logical architecture overview

Describe the top level software components and their interactions/relationships.
Use UML package diagrams and/or layer diagrams and/or interface diagrams.
Describe also the operating systems on which the software runs.

2.3.1 Software Component 1 description

Describe the content of each top-level software component in the architecture
Optional, you may not do it for 2 rationales:
1. Either your software is not class C according to IEC 62304
2. Or you describe each top level component in a SDD.

The description should contain:

• Its identification
• The purpose of the component,
• Its interfaces with other components,
• Its network interfaces,

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 System Architecture Description of XXX

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• The hardware resources it uses, for example: average RAM usage, peak RAM usage and
peak frequency and duration, disk space for permanent data, disk space for cache data,
average CPU usage, peak CPU usage and peak frequency and duration …

2.3.2 Software Component 2 description

Repeat the pattern for each top-level component.

2.3.3 Software Component 3 description

Repeat the pattern for each top-level component.

2.4 Software SOUP

If you use SOUP (Software Of Unknown Provenance), list them here.
For each SOUP, describe:
• Its identification and version
• Its purpose
• Where it comes from: manufacturer, vendor, university …
• Wether it is maintained by a third party or not
• If this is an executable,
o What are the hardware / sotfware resources it uses
o Wether it is insulated in the architecture and why
• Its interfaces and data flows
• Which SOUP functions the software uses
• How the SOUP is integrated in the software
• What hardware/software resources it requires for proper use

Note: have a look at FDA Guidance « Off-The-Shelf Software Use in Medical Devices » to
determine if you need specific or special documentation for your COTS.

If there is a list of known bugs on your COTS, you may add here this list with a review of their
consequences in terms of software failure and patient safety. If there are concerns about known
bugs, they should be treated by the risk analysis process.

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 System Architecture Description of XXX

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3 Dynamic behavior of architecture

The architecture was designed to answer to functional requirements.
For each main function of the system, add a description of the sequences / data flow that occur.
Use sequence diagrams, collaboration diagrams

3.1 Workflow / Sequence 1

Describe here the workflow / sequence of a main function
For example, the user queries data, what happens, from his terminal to the database.

3.2 Workflow / Sequence 2

Repeat the patern for each main function of the system

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 System Architecture Description of XXX

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4 Justification of architecture

4.1 System architecture capabilities

Describe here the rationale of the hardware / software architecture in terms of capabilities:
• Performances (for example response time, user mobility, data storage, or any functional
performance which has an impact on architecture)
• User / patient safety (see §4.3 and §4.4)
• Protection against misuse (see 4.4)
• Maintenance (cold maintenance or hot maintenance),
• Adaptability, flexibility
• Scalability, availability
• Backup and restore
• Hardware and Software security : fault tolerance, redondancy, emergency stop, recovery
after crash …
• Administration,
• Monitoring, audit
• Internationalization

4.2 Network architecture capabilities

If the medical device uses/has a network, describe here the rationale of the hardware / network
architecture:
• Bandwidth
• Network failures
• Loss of data
• Inconsistent data
• Inconsistent timing of data
• Cyber security (see FDA Guidance on Cyber Security of networked medical devices)

4.3 Risk analysis outputs

If the results of risk analysis have an impact on the architecture, describe here for each risk
analysis output what has been done to mitigate the risk in the architecture.
Use diagrams if necessary, like architecture before risk mitigation and architecture after risk
mitigation, to explain the choices.

4.4 Human factors engineering outputs

If (by any chance) the results of human factors analysis have an impact on the architecture,
describe here for each risk output what has been done to mitigate the risk in the architecture.

4.5 Regulation on personal data

If HIPAA or EU Regulation 2016/679 (GDPR) are applicable, describe here how the architecture
is compliant to these regulations. For GDPR, see articles 25 and 32.

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 System Architecture Description of XXX

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4.6 SOUP integration

If the software architecture has a particular structure dedicated to SOUP integration, it can be
described here. For example a wrapper of the SOUP, or an external process + a socket
communication, …

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 System Architecture Description of XXX

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5 Requirements traceability
Add a table with traceability of components of this document with functional requirements.

Requirement Component Comment

REQ-001 COMPO-001: foo maker COMP-001 does foo.
The device shall do foo COMP-002 also does
verification of foo result.

This may be a difficult job. A high level function is usually handled by many components. In this
case, quote only the component(s) which has(have) the major role.

This Template is the property of Cyrille Michaud

License terms : see http://blog.cm-dm.com/post/2011/11/04/License