ISO 13485 Awareness & Implementation

About Course

Course Overview
This course introduces the quality management requirements commonly applied to organizations involved in the medical device life cycle, including design, production, installation, servicing, distribution, and post-market support.
The focus is on documented processes, regulatory alignment, risk-based controls, traceability, validation, supplier management, complaint handling, and corrective action needed to maintain product safety and effectiveness.

Who Should Attend
– Quality managers
– Regulatory personnel
– Manufacturing and engineering teams
– Medical device distributors and service providers

Training Method
– Lecture
– Clause walkthrough
– Case examples
– Process mapping

Course Modules
– ISO 13485 Framework and Regulatory Context
– Documented QMS Processes and Traceability
– Risk Management, Validation and Production Control
– Supplier Control and Purchased Product Management
– Feedback, Complaint Handling and CAPA