Modern and Kinesthetic Techniques of Learning.Individuals interested to pursue a career in Medical Devices Quality Management.Individuals involved in Medical Devices Quality Management.Incident reporting & CAPA process (Course of action and required formats).Special emphasis on US and European Market. Insight into the foreign body requirements for medical devices.Risk Analysis and validation of Process (Clean room & sterilization) as per ISO 14971, ISO 14644 & ISO 11135.Process approach, 7 Quality principles, risk based thinking, quality policy & objectives and management review & internal audit.Important Processes of Quality Management System and their significance.Importance of Quality Management System with respect to ISO 13485 and Medical Devices.ISO 13485 Training Objectives The objectives of ISO 13485 Training are:
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