Quality & Regulatory
EU Authorized Representative
The EU authorized representative for Micropace as of 1st September 2008:
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.
Micropace Quality Policy Statement
Micropace and its staff will be the premier worldwide suppliers of cardiac stimulation-related products through the following QUALITY COMMITMENTS:
- Fulfil and exceed our customer’s, that is patient’s, doctor’s and distributor’s needs in the field of cardiac stimulation through…
- Delivery of quality and value products and services which are effective, safe, reliable and timely while …
- 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:
- Seeking from customers post-market feedback on current products and anticipating future needs from analysis of customer complaints, literature and conferences.
- Modifying, improving and developing products in response to market needs and opportunities.
- Using controlled traceable design process with defined quality planning, risk management, documented requirements and verification and validation plans.
- Reviewing, improving and inventing new product designs and company processes in production, delivery and service to improve quality and efficiency.
- Using customer complaints to promote ourselves, to improve product and comply with regulations.
- Implementing a regulations-compliant QMS supportive of our small size, employee expertise, agility and inventiveness.
- 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”.
- 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