ISO 13485:2003 Quality Management Systems - Medical Devices-system requirements for regulatory purposes "Refresher Course" (1 day)

(This course must be booked through the Qserve website)

Course Description:

This one-day “refresher” course offers medical device industry professionals the opportunity to immerse themselves in the requirements of ISO 13485. The “best practice” for development, implementation and maintenance of a quality management system according to ISO 13485, is considered. Current thinking in the interpretation of ISO 13485 is reviewed.

In the question and answer session that follows, an opportunity is given to discuss specific clauses of the standard and to address particular problems that participants may have encountered in the application of this norm.

Course Objectives:

• To provide participants with a better “in-depth” understanding of the requirements of ISO 13485
• To guide participants in the “best practice” for meeting the requirements of ISO 13485

Who should attend:

Prior knowledge and experience of ISO 13485 is required. The course is intended for:

• Quality Managers
• Operational managers
• RA Managers
• Internal Auditors
• Management Representative
• Members of the production team responsible for implementing the standard.

Course Materials:

Participants will receive a comprehensive course manual with reference materials, and, upon successful completion of the course, a “certificate of attendance”.

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