ISO 13485 · Quality management
Medical device quality-management system · ISO 13485:2016
What this means for your family
Quality-management evidence helps you ask how software development, changes and corrective action are controlled.
- Certificate
- 3050251115129MD
- Certification body
- QRO Certification LLP
- Certified
- 25 November 2025
- Stated expiry
- 24 November 2028
What this supports
The supplied certificate covers the named company’s quality-management scope for the design, development, deployment, maintenance and support of the specified SaMD.
Scope & limits
Certification applies to the certificate’s system scope. Historic “diagnostic mapping” wording does not extend the later MD-5’s non-diagnostic intended use. Accreditation-chain and live certificate status have not been independently checked.
First surveillance date shown: 24 November 2026.
Source: Original ISO 13485 certificate, p1.
Reviewed: · Current issuer or registry status: not independently confirmed.
This page summarizes the listed evidence; it is not an issuer’s verification service. A source review is separate from checking current issuer status.