Writing a Software Development and Maintenance Plan for IEC 62304 (Medical Device Compliance)
Dr. Oliver Eidel
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Clinical Evaluation
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Published May 08, 2021
Let's write a Software Development and Maintenance Plan for CrowdCovid.
We start writing our first regulatory document. Exciting!
Let's go through the template for the Software Development and Maintenance Plan, talk about these things and fill them out while doing so:
- Relevant processes: The processes you'll be using during your software development.
- Programming languages: The programming languages your software is written in (and how to document them).
- Development software: The development software you're planning to use, e.g. your IDE.
- System requirements / target runtime: Where your code will be executed including hardware requirements for your server.
- "Avoiding common software defects based on selected programming technology": How to come up with a reasoning to fulfil this 62304 requirement.
- Configuration management and version control
- Documentation activities
- Verification activities
- Software system test activities
Check out the template for the Software Development and Maintenance Plan on our website:
https://openregulatory.com/software-development-maintenance-plan-template-iec-62304/
This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information:
https://openregulatory.com/courses/the-wizard/
We start writing our first regulatory document. Exciting!
Let's go through the template for the Software Development and Maintenance Plan, talk about these things and fill them out while doing so:
- Relevant processes: The processes you'll be using during your software development.
- Programming languages: The programming languages your software is written in (and how to document them).
- Development software: The development software you're planning to use, e.g. your IDE.
- System requirements / target runtime: Where your code will be executed including hardware requirements for your server.
- "Avoiding common software defects based on selected programming technology": How to come up with a reasoning to fulfil this 62304 requirement.
- Configuration management and version control
- Documentation activities
- Verification activities
- Software system test activities
Check out the template for the Software Development and Maintenance Plan on our website:
https://openregulatory.com/software-development-maintenance-plan-template-iec-62304/
This is a free video of our Wizard video course which gives you easy-to-follow, step-by-step instructions on how to create your documentation for your medical device. Take a look at our website for more information:
https://openregulatory.com/courses/the-wizard/
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I’m a medical doctor, software engineer and regulatory dude. I’m also the founder of OpenRegulatory.
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
Through OpenRegulatory, I’ve helped 100+ companies with their medical device compliance. While it’s also my job that we stay profitable, I try to dedicate a lot of my time towards writing free content like our articles and templates. Maybe that will make consulting unnecessary some day? :)
If you’re still lost and have further questions, reach out any time!
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