ISO 13485 : 2003

ISO 13485 : 2003 (Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes)

QA Management has extensive experience in the application of this standard to medical devices.  The EEC under its Directive 93/42 requires for medical devices to be produced under the Quality Management System ISO 13485.  All medical devices placed on the marketplace must carry the CE Mark.  QA Management will assist companies in obtaining ISO 13485 and meet the CE Marking requirements.  The Company will also act as the European Representative for non European manufacturers.

Please refer to our training section for details on training courses applicable to this standard.

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