Quality & Regulatory

EU Authorized Representative

The EU authorized representative for Micropace as of 1st September 2008:

EC / REP

Advena Ltd, Pure Offices, Plato Close, Warwick CV34 6WE UK   

Quality Commitment - EPS320 Cardiac Stimulator

Micropace Pty Ltd maintains its commitment to quality through the following certifications and country approvals:

  • EU: Certified by BSI Group UK to Directive 93/42/EEC Annex II (CE0086).
  • QMS: Certified by BSI Group UK to ISO 13485:2016.
  • USA: 510(k) accepted by FDA, K011826 and K072200.
  • Australia: ARTGs certified via EU CE Certificate/Manufacturer Evidence for compliance to Esstential requirements required by TGA.
  • Japan: Accredited Manufacturer, BG60100005, products Shonin Approval No. 21900BZX00811000.  
Micropace Quality Policy

Quality Policy

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