Open QMS is a FREE resource for you to build your robust Quality Management System in compliance with ISO 13485.

Within Open QMS, you'll find the following:

FORMS / TEMPLATES

Tried and true documentation that you can put to work for your DHF, DMR, and QMS.

VIDEO GUIDANCE

Video lessons are provided on best practices for quality management and usage of the tools embedded within Open QMS.

COMMUNITY

Have questions or need feedback on Quality and Regulatory topics? Leverage the community to gain learn, improve, and help others in their MedTech journeys.