Risk Management for Medical Devices - ISO 14971:2019

2- Day Training for RA/QA Professionals of the MD Industry

Risk Management for Medical Devices - ISO 14971:2019

Maryland | August 4-5, 2020 | Register Now!

About the training

ISO 14971 covers a vast array of medical product types and technical disciplines to address specific classes of risk, such as usability, software, and biocompatibility. The Medical Device Directives require implementation of a Quality Management System, for which the harmonized standard is ISO 13485. This Standard also details requirements for demonstration of risk management. ISO 14971 is the harmonized standard for risk management; meeting standard demonstrates compliance to the requirements.

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.

Therefore, 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.

During this 2- day course, you will learn to:

• Identify integration of risk into the European Union (EU) Medical Device Regulation (MDR), the Medical Device Single Audit Program (MDSAP).
• Describe the purpose, structure, and key concepts of ISO 14971, including the definitions for benefit, state of the art, and reasonably foreseeable misuse and the expanded requirements for production and post-production activities.
• Understand the relationship of ISO 14971 to ISO 13485, IEC 60601, IEC 62304, IEC 62366, and ISO 10993.
• Identify software risk management expectations in IEC 62304
• Articulate the requirements for each step of the risk management process, including risk management planning, risk analysis, risk evaluation, risk control, benefit-risk and residual risk analysis, risk management review and reporting, and production and post-production activities.

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Keywords:  European Medical Devices Regulation 2017/745, Quality Management System (QMS) , Essential Principles, Technical File Documentation, Regulatory Requirements, Compliance, Risk Management, Electrical Safety (IEC 60601-1), Medical Device Electrical Safety, ISO 14971:2007, IEC 62366-1:2015), MDSAP, Medical Device Audit, Medical Device Single Audit Program (MDSAP), EN 62304, Software Lifecycle, ISO 14971:2019

WHO SHOULD ATTEND

• Medical Device Manufacturers: Senior Management, Regulatory Affairs Managers and Quality Managers, R& D specialists, Development, Manufacturing and Marketing Managers,
• Internal and external Auditors
• Importers
• Distributors

REQUIRED LEVEL

• General knowledge of Risk Management for Medical Devices - ISO 14971:2019

The number of participants is maximized to fifteen to provide a stimulating and practical working environment.

EDUCATIONAL RESOURCES

• Presentations
• Practical working sessions
• Course evaluation
• Lunch meeting with the trainer (Lead Auditor and Technical File Assessor for high risk devices)

LEARNING OBJECTIVES

• Understand the methodology of risk management for medical devices according to standard EN ISO 14971
• Understand the terms and vocabulary in order to document the process and demonstrate that the implemented method meets the requirements of standard
• Identify tools that can be used under this approach
• Understand all the elements needed for the technical documentation to address the requirements of directives 93/42/EEC and 90/385/EEC

DAY 1 & 2

8:30 am to 9:00 am – Breakfast

9:00 am – 12:15 pm       

• Identify and analyze hazards of product, process, or service.
• Create a process map.
• Perform fault tree analyses.
• Perform failure mode and effects analyses.
• Perform hazard analysis and critical control points.

12:15 pm - 1:00 pm - Lunch

1:00 pm- 5:30 pm           

• Perform hazard analysis and critical control points.
• Understand and analyze software hazards.
• Understand basics of human factors and its relationship to risk management.
• Begin performing risk management in your company.
• Course evaluation, synthesis and conclusions

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About the trainer

Mohamed Alsaadi  Certification Project Manager/Lead Auditor Mr. AlSaadi joined the GMED NA Team in 2012 and has been working as a Certification Project Manager /Lead Auditor since then, holding a B.Sc. in Biomedical Engineering. Before joining GMED NA, Mr. AlSaadi, worked in the medical field as a Field Engineer, supplier management and conception. He has been working with medical device manufacturers worldwide, auditing their regulatory and voluntary certification.