Educational purpose only
This website and all content, lessons, templates, forms, and generated outputs are provided solely for educational and informational purposes. Nothing on this website constitutes legal, regulatory, or professional compliance advice. This material must not be used as the basis for any regulatory submission, conformity assessment, quality management system, or compliance decision. You should not rely on this website as a substitute for consultation with qualified regulatory, legal, or quality management professionals.
No warranties or guarantees — content may contain errors
All content is provided "as is" and "as available" without warranties of any kind, whether express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, accuracy, completeness, or non-infringement. The material may contain factual errors, outdated information, or inaccuracies. Regulatory requirements change frequently, and the authors make no guarantees that the information is current, correct, or complete, or that use of this website will satisfy any regulatory requirement. The authors accept no responsibility for any errors, omissions, or consequences arising from the use of this material.
Limitation of liability
In no event shall the authors, contributors, or licensors be liable for any direct, indirect, incidental, special, consequential, or punitive damages arising out of or related to your use of or inability to use this website, including but not limited to regulatory non-compliance, failed audits, rejected submissions, product recalls, or any other commercial or legal consequences.
Not a regulated quality system
This website does not constitute a quality management system, does not meet the requirements of ISO 13485, EU MDR 2017/745, or any other regulatory standard, and must not be used as a controlled document system. All outputs require independent review, validation, approval, and controlled release within a compliant QMS before any regulated use.
Third-party content
Template content is adapted from OpenRegulatory Templates under CC BY-NC-SA 4.0. References to EU regulations, ISO standards, and IEC standards are for informational purposes only. This website is not affiliated with, endorsed by, or associated with any regulatory authority, notified body, or standards organization.
Verify against primary sources
Learners must independently verify all information presented on this website against the primary legal texts, official guidance documents, and current regulatory authority publications. Regulations, guidance, and standards are subject to amendment, correction, and reinterpretation. The primary sources — including Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), European Commission guidance, MDCG documents, and applicable national legislation — are the only authoritative references. This website is not a primary source.
Your responsibility
You are solely responsible for determining the suitability of any content, template, or output for your specific situation. This material is not intended to be relied upon for any regulatory purpose whatsoever. Use of this website is entirely at your own risk. By using this website, you acknowledge and agree to this disclaimer in its entirety.