Bharath Healthcare Laboratories Private Limited. (2026-09-19). ISO 13485 · Quality management. Pinnacle Verification Centre evidence summary. https://www.pinnacleblooms.org/verify/evidence/records/iso13485.html

original The supplied certificate covers the named company’s quality-management scope for the design, development, deployment, maintenance and support of the specified SaMD. 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. Original source: Original ISO 13485 certificate, p1.