Pre-Market QMS Toolkit for SaMD

This toolkit is intended for companies developing SaMD products and creating a quality management system from scratch. Our templates help you comply with 21 CFR 820 and ISO 13485 and get you through design and development stages. 

What's included:

• Downloadable templates in Microsoft Word and Excel formats
• Instructions and tips on how to implement the toolkit
• Access to updates, when applicable
• A 30-min call with Cosm

Interested in a specific template only? Contact us at templates@cosmhq.com. 

All templates are sold as-is, without any warranties or guarantees of functionality, compatibility, or fitness for a particular purpose. By purchasing, you acknowledge that modifications may be required to suit your specific needs. No refunds, exchanges, or customizations are provided. If you have any issues, feel free to reach out for general guidance, but support is not guaranteed