# iso-13485-standard

Published articles for iso-13485-standard.

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## Engineering Audits for ISO 13485 Medical Device Software Quality Management Systems

DevFeed: [Engineering Audits for ISO 13485 Medical Device Software Quality Management Systems](<https://devfeed.tech/articles/what-is-an-engineering-audit-like-26536.md>)

Original publisher: [Read original article](<https://annajmcdougall.medium.com/what-is-an-engineering-audit-like-dc2e09719efd?source=rss-51f15275ef3a------2>)

Author: Anna J McDougall

Published: 2025-08-18T20:21:35Z

Content type: article

Language: en

Sources: [Anna J McDougall](<https://devfeed.tech/sources/anna-j-mcdougall.md>)

Topics: [audit](<https://devfeed.tech/topics/audit.md>), [Requirements](<https://devfeed.tech/topics/requirements.md>), [Development](<https://devfeed.tech/topics/development.md>), [Software](<https://devfeed.tech/topics/software.md>), [systems](<https://devfeed.tech/topics/systems.md>)

Tags: [audit](<https://devfeed.tech/tags/audit.md>), [coding-style](<https://devfeed.tech/tags/coding-style.md>), [compliance](<https://devfeed.tech/tags/compliance.md>), [engineering](<https://devfeed.tech/tags/engineering.md>), [engineering-management](<https://devfeed.tech/tags/engineering-management.md>), [iso](<https://devfeed.tech/tags/iso.md>), [iso-13485-standard](<https://devfeed.tech/tags/iso-13485-standard.md>), [lifecycle](<https://devfeed.tech/tags/lifecycle.md>), [management](<https://devfeed.tech/tags/management.md>), [medical-devices](<https://devfeed.tech/tags/medical-devices.md>), [processes](<https://devfeed.tech/tags/processes.md>), [quality](<https://devfeed.tech/tags/quality.md>), [regulatory](<https://devfeed.tech/tags/regulatory.md>), [requirements](<https://devfeed.tech/tags/requirements.md>), [review](<https://devfeed.tech/tags/review.md>), [risk-management](<https://devfeed.tech/tags/risk-management.md>), [safety](<https://devfeed.tech/tags/safety.md>), [software](<https://devfeed.tech/tags/software.md>), [software-engineering](<https://devfeed.tech/tags/software-engineering.md>), [systems](<https://devfeed.tech/tags/systems.md>)

### AI overview

This case study explains what an engineering audit involves under ISO 13485 for medical device software. It covers Quality Management System documentation, lifecycle management, patient safety, risk management, regulatory requirements, and the author's experience updating engineering compliance documents.

### Source excerpt

What is an Engineering Audit Like? An ISO 13485 Medical Device Engineering QMS Case StudyI think I found my new look. If there's one thing that gets me fired up, it's a good ol'-fashioned audit! ... Said nobody ever. Sadly, audits are a part of the business world that tend not to be fun. However, they also serve an important purpose, and are part of the transition from the "fun team lead" style of management into the "business leader" role is coming to grips with the unsexy stuff. As part of my role at HelloBetter, I was tasked with leading engineering compliance and reporting for ISO 13485, an internationally recognised standard for Quality Management Systems (QMS) specifically for medical device manufacturers, within the broader context of the EU Medical Device Regulation (MDR). For those who aren't familiar with what an audit of this kind involves, the simple version is this: Certain requirements exist as part of the standard, not just about how to effectively create and maintain software, but also how to document that compliance. This documentation is referred to as the Quality Management System (QMS), which as the name implies serves as documentation for how you maintain quality as per the ISO. The ISO isn't only about software, but software is part of "Lifecycle Management", tracking how a medical device (in this case) goes from design and development to distribution and surveillance. A company required to meet the ISO should therefore create and follow a system that ticks all the boxes for things like patient safety, risk management, and any additional regulatory hurdles. Typically once a year, an auditor is hired to enter the company and review the documentation alongside representatives from the company who guide them through the QMS. Additionally, individuals (like me!) are pulled from different parts of the company to talk through their processes and documentation, and to show any examples that may be relevant. My Experience with Engineering Compliance for