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Disclaimer
This website, all toolkits, templates, and content are provided for informational and educational purposes only. They are not legal, regulatory, or professional advice. Use at your own risk. Always consult qualified professionals before making decisions.
No Warranties
The materials provided in the Change Control & Design Change Toolkit are provided "as is" without warranties of any kind, either express or implied. We do not warrant that the templates will meet your specific regulatory requirements, as these vary by jurisdiction, product classification, and regulatory pathway.
Limitation of Liability
In no event shall RegWatch Daily, its owners, employees, or affiliates be liable for any direct, indirect, incidental, special, or consequential damages arising out of or related to the use of the toolkit, templates, or any content on this website. This includes, without limitation, damages for loss of profits, business interruption, or loss of data.
Regulatory Compliance
The templates reference FDA 21 CFR Part 820 (Quality System Regulation), specifically §820.40 (Document Controls) and §820.30(i) (Design Changes), as well as ISO 13485:2016 §7.3.9. These templates are designed to help you build a compliant system, but compliance ultimately depends on your specific implementation, products, and regulatory context. You are solely responsible for ensuring your quality management system meets all applicable regulatory requirements.
Intellectual Property
Upon purchase, you receive a license to use, modify, and customize the templates for your organization's internal use. You may not redistribute, resell, or share the templates with parties outside your organization.
Refund Policy
Due to the digital nature of the product, all sales are final. If you experience any issues with your purchase, please contact us at leroy@regwatchdaily.com and we will work with you to resolve the matter.
Contact Information
For questions about these terms or the toolkit, contact us at leroy@regwatchdaily.com.