Template: Software Architecture Checklist

Sven Piechottka • IEC 62304 Templates • Published August 02, 2022 • Software Architecture

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Software Architecture Checklist

Regulatory references:

IEC 62304, para. 5.3.6 [class B, C]

Relevant other documentation:

SOP Software Development
User needs / stakeholder requirements
Design input / software requirements
Software architecture description
(...)

1. Checklist

Criteria	Pass / Fail
The software architecture is in agreement with the software requirements.	( ) Yes( ) Improve:
All software systems are listed and their respective safety class is stated.	( ) Yes( ) Improve:
All software components are listed and described, including interfaces.	( ) Yes( ) Improve:
All software units are listed and described.	( ) Yes( ) Improve:
(Optional) Further architecture is described, e.g. databases, security and data protection requirements.	( ) Yes( ) Improve:
The software architecture can be implemented with our given resources.	( ) Yes( ) Improve:

2. Comments

3. Results

( ) Software Architecture passed\
( ) Software Architecture not passed\
( ) Software Architecture passed with the following obligations: <Insert if applicable>\

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Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.

More about me