Quality is always the result of excellent work without compromise.
MMD-105 Understanding the Requirements of ISO 14971:2019 - Risk Based Thinking
Schedule and Hours
Implementation of ISO 14971:2019, is a one of the primary requirements while demonstrating the compliance to regulatory requirements and conformance to Quality Management Risk Management system requirements to ISO 13485 Standard for Medical Device and In-vitro Diagnostic device manufacturers.
While analyzing the reasons for the product failures, most of the time it leads to inadequacy in understanding and implementation of risk management in the organization. This training is to create awareness of requirements and to have better understanding.
Upon completion of the course, participants will be able to:
To have better planning and framework of risk management
To demonstrate compliance to regulations
To have structured approach while implementation
To learn the overview of risk management activities
To ensure product development with desired quality and safety standards
Integration of risk management into an existing Quality Management System
Section 1: Introduction to ISO 14971:2019
Section 2: Links to Regulatory Requirements
Section 3: Understanding of ISO 14971:2019 Standard and Implementation
Section 4: General Requirements for Risk Management System
Section 5: Risk Analysis
Section 6: Risk Evaluation
Section 7: Evaluation of Overall Residual Risk
Section 8: Risk Management Review
Section 9: Production and Post-Production Activities
Section 10: Application of Risk Management
Product Risk Managers
Research & Development
This is a 2-days programme. This course runs from 9:00am – 5:00pm with an hour for lunch and periodic short breaks.
This is an intensive session designed to include as much discussion as possible. Lunch and breaks provide an opportunity for further questioning and discussion with the instructors.
We are HRD Corp (Human Resource Development Corporation) Registered Training Provider. All of our training modules are claimable under HRD Corp.