Tag: Software Validation

Articles

Quality Management

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

Updated almost 2 years ago

Dr. Oliver Eidel

Questions

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

Anonymous

over 2 years 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

Accepted 1 answer

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

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Software Validation Procedure for ISO 13485 compliance?

Anonymous

over 2 years 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

Accepted 1 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

SOP Software Validation

Sven Piechottka

updated over 2 years ago

Software Validation Form

Sven Piechottka

updated almost 2 years ago

Software List

Dr. Oliver Eidel

updated over 2 years ago