Disclaimer

1. AI-Generated Content Warning

All content on Medevice.tech, including but not limited to:

• Regulatory update summaries and articles
• Explanatory content and analysis
• Educational guides and tutorials
• Template documents and checklists
• "Why It Matters" and "Action Points" sections

...is generated, summarized, or processed using artificial intelligence (AI) technologies, including OpenAI GPT-4 and Anthropic Claude models.

2. Accuracy and Reliability Limitations

Due to the nature of AI-generated content, you acknowledge that:

• Errors may exist: AI systems can misinterpret, misrepresent, or incorrectly summarize regulatory information
• Information may be outdated: Content may not reflect the most recent regulatory changes or amendments
• Context may be lost: Summaries may omit critical details, exceptions, or nuances present in original documents
• Technical errors possible: AI may misunderstand technical terminology or regulatory requirements
• No guarantee of completeness: Important information may be missing or overlooked
• Translations may be imperfect: Content translated from other languages may contain inaccuracies

3. Not Professional or Legal Advice

For regulatory compliance decisions, quality management system implementation, or any other professional matters, you should consult with:

• Qualified regulatory affairs professionals
• Licensed legal counsel specialized in medical device regulations
• Notified Bodies or conformity assessment bodies
• Official regulatory authorities directly

4. Intended Use

Medevice.tech is intended solely for:

• General awareness of regulatory developments
• Initial research and quick reference purposes
• Educational understanding of regulatory frameworks
• Identifying topics that require further investigation with official sources

5. Required Verification

Before taking any action based on information from Medevice.tech, you MUST:

1. Verify all information with the original primary source (official regulatory authority website)
2. Review the complete official document, not just summaries
3. Consult with qualified professionals as appropriate
4. Check for any updates or amendments published after our content date
5. Ensure compliance with your specific product and market requirements

6. Web Scraping and Data Sources

Medevice.tech aggregates information from various publicly available sources through automated web scraping. While we attempt to maintain accuracy, the scraping process may introduce errors, miss updates, or capture incomplete information. Source websites may change their structure or content without notice.

7. Limitation of Liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, MEDEVICE.TECH AND ITS OPERATORS SHALL NOT BE LIABLE FOR:

• Any regulatory non-compliance, fines, or penalties
• Product recalls, market withdrawals, or enforcement actions
• Delays in market access or regulatory approvals
• Business losses or damages of any kind
• Decisions made based on information from this website
• Any direct, indirect, incidental, consequential, or punitive damages

8. No Warranties

This website is provided "AS IS" and "AS AVAILABLE" without any warranties of any kind, either express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose, accuracy, or non-infringement.

9. Acceptance of Terms

By using Medevice.tech, you acknowledge that you have read, understood, and agree to be bound by this disclaimer. If you do not agree with these terms, please do not use this website.