The EU authorized representative for Micropace as of 1st September 2008:
|Advena Ltd. Thorne Widgery House, 33 Bridge Street, Hereford HR4 9DQ, UK|
Quality Commitment - EPS320 Cardiac Stimulator
Micropace Pty Ltd maintains its commitment to quality through the following certifications and country approvals:
|EU:||Certified by SGS UK to Directive 93/42/EEC Annex II (CE 0120).||EU:||Certified by SGS 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 SGS, CMDCAS Recognised Registrar to ISO 13485:2003.|
|Japan:||Accredited Manufacturer, BG60100005, products Shonin Approval No. 21900BZX00811000.|
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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:
- 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 ISO13485:2003 and regulations according to TGA, 21CFR820, MDD and Canadian Health MDR.