MMD-105 Understanding the Requirements of ISO 14971:2019 - Risk Based
Thinking
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.
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
- Quality Assurance
- Regulatory Affairs
- Research & Development
- Project Managers
- Operations Managers
- Manufacturing Managers
- Engineers
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.
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.
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