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Tag: Software Validation

Articles

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Dr. Oliver Eidel

Software Validation: How To Do It (Pain From Hell)

Dr. Oliver Eidel
updated 10 months ago

Questions

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Can We Use GitHub and Other SaaS For Our Software as a Medical Device?

Anonymous
updated about 1 year ago
We’re currently using SaaS tools like GitHub to host our code. Our consultant told us that that’s not okay and we need to self-host everything. His reason was that we’re only allowed to use tools whic
Dr. Oliver Eidel

Accepted answer

Your consultant is wrong. You can use GitHub. And look for another consultant. Long Answer The ISO 13485 requires you to “validate” all quality-relev

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Software Validation Procedure for ISO 13485 compliance?

Anonymous
updated about 1 year ago
We’re currently using GitHub for our code repositories. Now we’ve heard that this sort of software needs to be “validated”. What does that mean? Do we have to write tests for it? Do we need to self-ho
Dr. Oliver Eidel

Accepted answer

Don’t panic :) Yes, you have to validate software and it feels like overhead, but it’s manageable and not a huge effort. Write down your intended use

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Templates

Document Template
Sven Piechottka

Software Validation Form

Sven Piechottka
updated 9 months ago
Document Template
Dr. Oliver Eidel

Software List

Dr. Oliver Eidel
updated about 1 year ago
Document Template
Sven Piechottka

SOP Software Validation

Sven Piechottka
updated about 1 year ago