Quality Training

ISO 14971 - Risk Management for Medical Devices

Objectives

This intensive course will evaluate and focus on the requirements of the ISO 14971 in detail and will demonstrate Risk Management practices that reflect best in class practices. During the 2 days participants will acquire the knowledge and skills to implement an effective Risk Management system in conformance to ISO 14971. Risk Management, like any other system, evolves over time within a company as knowledge grows and frequent reviews are conducted. Hence, the best place to practice and extend your experience is in reviewing one’s current system, conduct a gap analysis and determine if current established requirements are sufficient to meet applicable regulatory requirements.

Course Objectives:

• Describe the purpose of a Risk Management system and explain the Risk Management Process elements.
• Explain the purpose, content and interrelationship of ISO 14971, ISO 13485, 21CFR820, MDSAP and EU MDR.
• Interpret requirements of ISO 14971.
• Define risk management.
• Describe most frequently used risk assessment tool.
• Define basic risk management terms.
• Identify risk management responsibilities.
• Describe the benefits of risk management.

Content includes

Day 1:

• Standards - Overall intent of ISO 14971 in relation to ISO 13485, 21CFR820 and MDSAP;
• Understanding of Risk Based Approach V Risk Management;
• Risk Management Overview;
• Risk Management Definitions;
• Analysing; Evaluating; Assessing; Controlling; Monitoring; Reporting; Post Market Surveillance; Management Responsibility
• Risk Management Lifecycle
• Overview of Frequently Used Risk Management Tools
• Application of RM to all aspects of Quality, Production and associated activities
  

Day 2:

• Risk Management - Recap Day 1
• Differentiating between Intended Use and Indications for Use
• Case study exercises on applying ISO 14971
• Risk Management Tools and sample Exercises
• How to identify and document Harms, Hazards and Hazardous situations
• Top Level - How to document Risk Management Plan
• Top Level - How to conduct a Hazard Analysis
• Top Level - How to cascade harms in a Fault Tree Analysis (FTA)
• Top Level - How to perform a PFMEA (Product/Process)
• Top Level - How to document Risk Management Report

Who should attend

All personnel involved in areas relating to Quality, Production, Engineering, Supplier and Outsourced Process Management should be conversant with these requirements to provide assurance of Competency in Medical Device Product Risk Management.

Upcoming dates: