Medical Certification
ISO 13485 Medical Devices QMS
Quality management system governing the design, development, and provision of medical devices and related services.
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72h Fast-Track Issuance
Professional Value Proposition
Global Recognition
Accepted by partners and regulators worldwide under the IECC supervision framework.
100% Impartiality
AI-driven auditing eliminates human bias and ensure consistent standard interpretation.
Verifiable Trust
Blockchain-secured digital signature for instant verification by any stakeholder.
About the ISO 13485 Medical Devices QMS Standard
The ISO 13485 Medical Devices QMS is a globally recognized benchmark for excellence within the Medical sector. By undergoing our AI-First audit process, your organization demonstrates a commitment to maintaining the highest standards of quality, security, and operational integrity.
Traditional certification can take months of expensive consulting and manual review. Our Hybrid AI flow streamlines this into a 3-day process:
Audit Package
$999.00 / audit
- Official Digital Certificate
- Verifiable QR Code Signature
- AI Audit Summary Report
- Embeddable Trust Badge
- Valid for 365 Days
No hidden fees. 100% money-back guarantee.
Sample Certificate
CERTIFICATE OF REGISTRATION
Certificate of Conformity
ISO 13485 Medical Devices QMS
This is to certify that the Management System of:
Your Organization Name
123 Business Ave, Tech City, Country
ISO 13485
Medical Devices QMS
Scope of Certification
Provision of services related to Medical Devices QMS. The scope includes all operational activities, software development, and customer support functions.
Certificate NoAQX-1233
Issue Date2026-01-15
Expiry Date2029-01-15
Verification IDAQX-6440
Accredited by IECCInternational Evaluation and Certification Center
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James Peterson
Director of Certification
Validity of this certificate is subject to successful annual surveillance audits.
Verify authenticity at: https://aqxcert.com/verify
Verify authenticity at: https://aqxcert.com/verify
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Frequently Asked Questions
Q.Is the ISO 13485 Medical Devices QMS certification valid globally?
Yes. Our certificates are issued under the supervision of the IECC (International Electronic Commerce Commission) and are recognized by major international partners and regulatory bodies engaged in digital trade.
Q.Do I need to undergo a physical on-site audit?
No. Our AI-First approach utilizes remote evidence collection and digital footprint analysis. Physical audits are replaced by rigorous algorithmic verification of your documentation and public data.
Q.How long is the certificate valid for?
The certificate is valid for 12 months (1 year) from the date of issuance. You will receive a renewal notification 30 days before expiration.
Q.What happens if my company fails the AI Audit?
If our initial scan detects gaps, we provide a detailed 'Gap Analysis Report' with specific remediation steps. You can re-submit for verification at no extra cost within 30 days.
Ready to Join the Global Compliance Network?
Apply today and get your ISO 13485 Medical Devices QMS certification processed by our AI audit engine. Join thousands of world-class businesses.
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