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Updated November 22, 2022

ISO 13485 Templates

Dr. Oliver Eidel

The ISO 13485 is the standard for quality management in the medical device industry. Here are all our posts on this standard, and also all questions our consulting clients have asked us about the ISO 13485 so far. Additionally, we publish all our document templates for the ISO 13485 for free, so scroll down and have a look at those! If you fill those out, you have a good chance of already being compliant with the standard, no consultants required :)

The best news is that we’ve published all our ISO 13485 templates for free! Check them out below.

Also note that we have many more templates besides the ones for ISO 13485 - head over to our templates page for more templates.

And finally, do you want to draft your own QMS with just one click? With Formwork, our eQMS software, combined with our free templates and a little bit of ChatGPT magic, you can draft your QMS in minutes. Check out the video below to see how it works.

All ISO 13485 Templates

Template: Internal Audit Report
Template: PRRC Appointment Letter
Template: Internal Audit Program
Template: Internal Audit Plan
Template: List of Regulatory Requirements
Template: SOP Sales
Template: List of Medical Device Consultants
Template: ISO 13485: Mapping of Requirements to Documents
Template: Training Record
Template: Software Validation Form
Template: SOP Software Validation
Template: List of Qualified Suppliers
Template: Supplier Checklist
Template: SOP Purchasing
Template: List of Training Documentation
Template: SOP Human Resources Administration
Template: SOP Clinical Evaluation
Template: Management Review Report
Template: SOP Management Review
Template: SOP Internal Audit
Template: SOP Product Certification and Registration
Template: SOP Update of Regulations
Template: Incident Assessment Form
Template: Field Safety Notice
Template: SOP Vigilance
Template: SOP Feedback Management and Customer Complaints
Template: Document List QMS
Template: Post-Market Clinical Follow-Up Report (PMCFR)
Template: Post-Market Clinical Follow-Up Plan (PMCFP)
Template: Periodic Safety Update Report
Template: Post-Market Surveillance Plan
Template: SOP Post-Market Surveillance
Template: Quality Manual, Policy, Objectives
Template: SOP Document and Record Control
Template: SOP Corrective and Preventive Action (CAPA)
Template: CAPA List
Template: Software List

Questions Other Companies Ask Us About ISO 13485

Can We Use GitHub and Other SaaS For Our Software as a Medical Device?
Software Validation Procedure for ISO 13485 compliance?

All ISO 13485 Articles

MDR Post-Market Surveillance: The Ultimate Guide
ISO 13485 KPIs: Example Key Performance Indicators For Your ISO 13485 Processes
CAPA (Corrective and Preventive Action): What Is It and How To Be Compliant?

On a slighty different note: You want to get your medical software certified under MDR but don't know where to start? No worries! That's why we built the Wizard. It's a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you're looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We've built Formwork, and it even has a free version!

If you're looking for human help, did you know that we also provide some limited consulting? It's limited because we are not many people. We guide startups from start to finish in their medical device compliance.

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Dr. Oliver Eidel

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!

No QMS on this planet will save you from creating crappy software.