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Quality Assurance |
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The Alpha-Bio Tec Quality System commitment is to ensure that Alpha-Bio Tec's medical devices are with compliance to international standards and requirements.
To ensure constant adequacy and effectiveness to these standards and to comply with all regulatory requirements Alpha-Bio Tec maintains a high standard of Quality Assurance system.
Alpha-Bio Tec's Medical devices are:
• CE-approved.
• Clear for marketing in the USA.
Alpha-Bio Tec complies with major quality control standards:
• ISO 13485:2003 including the Canadian Medical Devices Conformity Assessment System.
• ISO 9001:2000.
• Council Directive 93/42/EEC. |
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