Certificates

• CEMarked
• ISO13485:2016
• WHOGMP
• 10certificates

3 certificates

Quality Management Systems

The systems an auditor or regulator checks first — how the company designs, makes and controls its devices.

ISO 13485:2016Medical devices — Quality management systemsDIQC · NetherlandsEN/00426/01View certificateISO 13485:2016Medical devices — Quality management systemsDIQCSDI260402View certificateISO 9001:2015Quality management systemsRAPL · accredited by EGACE2024038805View certificate

2 certificates

Regulatory & Market Access

The documents a distributor or importing regulator asks for before a device may be sold in their market.

WHO-GMPGood Manufacturing PracticeInternational Standards RegistrationsISRG160RView certificateFree Sale CertificateSale in domestic market & for exportDrugs Controller · KarnatakaFSC/MD/2026/000108View certificate

2 certificates

Notified Body Assessment

Full Quality Assurance certificates issued by DNV, Notified Body 2460, under Medical Devices Directive 93/42/EEC.

DNV EC CertificateFull Quality Assurance — absorbable suturesDNV · Notified Body 246010000322028View certificateDNV EC CertificateFull Quality Assurance — non-absorbable rangeDNV · Notified Body 246010000322027View certificate

3 certificates

Statutory & Tender Compliance

Indian statutory documents a tender committee checks — standing to supply and a clean compliance record.

Market Standing CertificateEligibility to supply in tendersCDSCO · Government of IndiaMSC/MD/2026/000416View certificateNon-Conviction CertificateClean regulatory compliance recordCDSCO · Government of IndiaNCC/MD/2026/000593View certificateNon-Conviction CertificateClean regulatory compliance recordDrugs Controller · KarnatakaNCC/MD/2026/000829View certificate

Certificates are issued in English by the bodies named. Opening a certificate shows the original document.