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Tag: ISO 13485

The ISO 13485 is the standard for quality management in the medical device industry. This page is a collection of all our articles on this quality management standard. We also publish all our document templates for the ISO 13485 for free and you can find them below!

Articles

Quality Management

Post-Market Surveillance: The Ultimate Guide under MDR

Updated almost 2 years ago
S

Sebastian Skorka

Quality Management

ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes

Updated almost 2 years ago

Dr. Oliver Eidel

Quality Management

CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?

Updated almost 2 years ago

Dr. Oliver Eidel

Questions

A

Flowcharts For ISO 13485: Should We Add Flowcharts To SOPs?

Anonymous
about 2 years ago
We're starting to document our processes for ISO 13485 compliance. For that, we're using the OpenRegulatory SOP templates. However, we're also wondering whether we should add flowcharts to those becau
Accepted 1 answer

No. Long AnswerLook, I get it, flowcharts in SOP documents look great and are actually more readable than the actual document. Like, if you're trying

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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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