Risk Management Applied to Medical Devices (ISO 14971:2019)

ABOUT THE TRAINING

Training Time: 2 full-day sessions: June 15, 10am - 6pm; June 16, 10am - 6pm EDT

Risk management goes beyond development and manufacturing; it is a vital part of all your company’s processes. ISO 14971 defines the international requirements of risk management systems for medical devices, defining best practices throughout the entire life cycle of a device.

To ensure your company gets a safe, effective product to market on time and within budget, you need a successful implementation of your risk management system.

With the newly updated ISO 14971:2019 standard, GMED North America has created a 2-day training session, to equip medical device manufacturers with the right understanding and implementation of the Risk Management for Medical Devices – ISO 14971:2019.

REQUIRED LEVEL

• General knowledge of Risk Management for Medical Devices principles
• Global knowledge of the European Medical device regulation: Directive 93/42/EEC and regulation (EU) 2017/745.

WHO SHOULD ATTEND

• Regulatory Affairs Managers
• Quality Managers
• R&D and Manufacturing Managers
• Internal and external Auditors

LEARNING OBJECTIVES

• Know the standard’s vocabulary and principles
• Understand the purpose, structure, and key concepts of ISO 14971
• Know the risk management methodology for medical devices described in standard EN ISO 14971
• Understand the risk management approach through regulation

EDUCATIONAL RESOURCES

• Presentations
• Practical working sessions
• Course evaluation

AGENDA

Program

• Objectives of ISO 14971 standard and associated vocabulary
• Standard General requirements
• Standard Methodology (different steps)
• Risk Management and usability
• Risk Management within the EU Medical Device Regulation
• ISO 13485 requirement – risk management approach
• Practical working sessions
• Group workshop
• Course Evaluation
• Summary and Discussion with the trainer

About the Trainer

Ibim Tariah, Senior Advisor Regulatory Strategy and Product Reviewer at GMED NA

Dr. Ibim Tariah is a Senior Advisor Regulatory Strategy and Product Reviewer at GMED North America. He graduated from the University of Manchester, U.K. with a doctorate degree in Materials Science with emphasis on polymer science and technology. Ibim previously worked at R&Q Solutions LLC as Vice President, EU MDR & IVDR Services providing leadership, strategic advisement, and was previously the Technical Director at BSI where he worked for 21 years.

As a Senior Advisor Regulatory Strategy and Product Reviewer, Ibim is responsible for Regulatory Strategy development activities and implementation, including liaison with both GMED HQ and other Regulatory Agencies and provide expertise to support GMED Commercial, Technical & Regulatory Compliance activities.