Areas Covered in the Session:
ISO 13485 2015 versus ISO 13485 2003
Overview of ISO 13485 2015
Systemic Requirements
Management Requirements
Resource Requirements
Realization Requirements
Remedial Requirements
Who Will Benefit:
Managers, Supervisors, Directors, and Vice-Presidents
R&D
Manufacturing Engineering
Design Assurance
Quality Assurance
Operations
Document Control
Speaker Profile :
Jose Mora is a Principal Consultant specializing in Manufacturing Engineering and Quality Systems. For over 30 years he has worked in the medical device industry specializing in manufacturing, process development, tooling, and quality systems. Prior to working full time as a consulting partner for Atzari Consulting, José served as Director of Manufacturing Engineering at Boston Scientific and as Quality Systems Manager at Stryker Orthopedics, where he introduced process performance, problem solving, and quality system methodologies.
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