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).
  • EU: Certified by BSI Group UK to ISO 13485:2003.
  • USA: 510(k) accepted by FDA, K011826 and K072200.
  • Australia: Certified to Full Quality Assurance Procedures by the Department of Health and Ageing, Therapeutic Goods Administration, Australian Government.
  • Canada: Certified by BSI Group, CMDCAS Recognised Registrar to ISO 13485:2003.
  • Japan: Accredited Manufacturer, BG60100005, products Shonin Approval No. 21900BZX00811000.  
Australia

Australia

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QMS

QMS

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MDD

MDD

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Micropace Quality Policy Statement

Micropace and its staff will be the premier worldwide suppliers of cardiac stimulation-related products through the following QUALITY COMMITMENTS:

  1. Fulfil and exceed our customer’s, that is patient’s, doctor’s and distributor’s needs in the field of cardiac stimulation through…
  2. Delivery of quality and value products and services which are effective, safe, reliable and timely while …
  3. Maintaining compliance with quality requirements of ISO13485:2012 and regulations according to TGA, 21CFR820, MDD and Canadian Health MDR, Japanese Ministerial Ordinance #169.

We will achieve this by following ACTIONS:

  1. Seeking from customers post-market feedback on current products and anticipating future needs from analysis of customer complaints, literature and conferences.
  2. Modifying, improving and developing products in response to market needs and opportunities.
  3. Using controlled traceable design process with defined quality planning, risk management, documented requirements and verification and validation plans.
  4. Reviewing, improving and inventing new product designs and company processes in production, delivery and service to improve quality and efficiency.
  5. Using customer complaints to promote ourselves, to improve product and comply with regulations.
  6. Implementing a regulations-compliant QMS supportive of our small size, employee expertise, agility and inventiveness.
  7. Management and workers embracing our QMS, and adopting and updating their SOP’s and WI with a motto – “Our QMS – know it, use it … or change it”.
  8. Regular Management Reviews of QMS’s effectiveness and efficiency using up-to-date quality requirements, the CAPA’s system, risk assessment, gap analysis and customer and employee feedback.

 

Last updated Date: 21st May 2016