ISO 13485: 2003 - A Straightforward Interpretation with Recommendations for Easy Implementation

Overview:

Development, implementation, and maintenance of an ISO 13485-compliant quality management system requires many resources and personnel to meet with success.

ISO 13485 is a wordy standard, drafted by individuals for many of whom English is not their primary language. This webinar is a section-by-section review of ISO 13485 in a clear concise manner, and provides suggestions for development of a compliant system. 

Areas Covered in the Session:

• The purpose of the standard
• The structure of the standard
• The requirements of the standard
• Straightforward recommended implementation approach

Who Will Benefit:This webinar will provide valuable assistance to all device manufacturers who wish to have a better understanding of the requirements of ISO 13485. The employees who will benefit include:

• Top management
• Regulatory Management
• Quality Management
• Documentation Managers
• Quality Engineers
• Other personnel involved in development and implementation of the QMS

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