Dolphin Sutures

Certificados

A Dolphin Sutures tem compromisso com a qualidade. Conheça nossos certificados e nossos processos de garantia da qualidade para nossos produtos médicos.

  • EU MDR2017/745
  • ISO13485:2016
  • WHOGMP
  • 12certificates

3 certificates

Quality Management Systems

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

3 certificates

Regulatory & Market Access

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

2 certificates

Notified Body Assessment

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

4 certificates

Statutory & Tender Compliance

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

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