ISO 13485:2016 — Gap Analysis
Medical Devices — Quality Management System (QMS)Your Name
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ISO 13485 Assessment Progress
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1. Information We Collect
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Email: info@iso-xpert.com | Phone: +44 7853 109840
Terms of Use
Please read these Terms carefully before using the ISO Xpert ISO 13485 Gap Analysis Tool ("the Tool") and website at iso-xpert.com, operated by ISO Xpert Ltd ("ISO Xpert", "we", "us"). By accessing or using the Tool, you agree to be bound by these Terms.
1. Ownership and Intellectual Property
The ISO Xpert ISO 13485 Gap Analysis Tool, including all content, design, text, structure, branding, and code, is the exclusive intellectual property of ISO Xpert Ltd. All rights reserved.
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2. Permitted Use
- Use the tool to assess your organisation's compliance with ISO 13485:2016.
- Export and retain generated reports for internal records.
- Share exported reports within your organisation.
3. Prohibited Use
- Redistribution, resale, or sublicensing of this tool.
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- Using the tool for unlawful purposes.
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4. Important Medical Device Disclaimer
This Tool is provided "as is" for informational and self-assessment purposes only. ISO Xpert does not provide regulatory, legal, or clinical advice. This tool must not be used as the sole basis for regulatory submissions, CE marking decisions, FDA 510(k) filings, MDR/IVDR compliance assessments, or any other regulatory activity relating to medical devices. Outputs must be reviewed by a qualified ISO 13485 consultant and a regulatory affairs specialist before any regulatory decisions are made.
The medical device industry is subject to strict regulatory requirements including EU MDR 2017/745, EU IVDR 2017/746, FDA 21 CFR Part 820, and other applicable national regulations. Users are solely responsible for ensuring compliance with all applicable laws and regulations in their jurisdiction.
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To the fullest extent permitted by applicable law, ISO Xpert Ltd shall not be liable for any indirect, incidental, special, consequential, or regulatory damages arising from your use of, or inability to use, this Tool.
6. ISO Standards Reference
References to ISO 13485:2016 within this tool are for guidance only. The authoritative version is published by ISO and must be obtained directly from ISO or national standards bodies. ISO 13485 is harmonised with EU MDR/IVDR and other regulatory frameworks — users must verify current harmonisation status.
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9. Contact
ISO Xpert Ltd
71-75 Shelton Street, Covent Garden, London WC2H 9JQ, UK
Email: info@iso-xpert.com | Phone: +44 7853 109840