Medical Devices QMS ISO 13485 Foundation & Internal Auditor Training

DESCRIPTION

This course is designed to familiarize quality and regulatory professionals, medical device designers and management with the additional requirements of ISO 13485:2003 and their interpretation. The quality system of requirements of EC directives 93/42/EEC (medical devices) and 98/79/EC (in vitro diagnostic medical devices) are also included to allow full understanding of quality systems required to achieve CE marking. The training has been designed to give you the necessary skills to perform internal audits on an organization’s Quality Management Systems (QMS) for Medical Devices to the requirements of ISO 13485:2003 and to contribute to their continual improvement.

OBJECTIVES

Upon successful completion of this course, delegates will be able to:

Understand the requirements of ISO 13485:2003 and their interpretation
Understand the quality system requirements of EC directives 93/42/EEC and 98/79/EC
Prepare quality management system documentation to meet ISO 13485:2003, and EC Directives 93/42/EEC and 98/79/EC
Use the references and guidance documents available to further enhance their understanding of quality systems for medical devices
Apply ISO 13485:2003 requirements to their internal audits, supplier audits and third party audits of medical devices manufacturers

AUDIENCE

This training is suitable for employees who have to implement the requirements of the QMS for medical devices within their organization, including employees responsible for Quality Assurance and/or Regulatory Affairs and employees who have to audit organizations against the provisions of the QMS ISO 13485.

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CLASSROOM (2 CLASSES) 3 DAYS

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