Risk management applied to Medical Devices (ISO 14971:2019)
Understand the requirements for implementing a successful risk management system
2-day training session | Virtual Classroom
About the training
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.
Trainers
Amy Chan
Product Reviewer, GMED North America
Amy is a seasoned medical device professional with 15 years of extensive experience in the pharmaceutical and medical device fields. Throughout her career, she has worked as an engineer in research and development, manufacturing, and quality assurance at renowned medical device companies such as Medtronic, Abbott Vascular, Allergan and AbbVie. In these roles, she has served as a pivotal part in facilitating the market entry of innovative and life-saving medical devices. For the past 5 years, Amy has worked as a product reviewer at notified bodies specializing in the review of non-active cardiovascular devices.
Amy is currently a product reviewer in Cardiology at GMED North America. Amy holds a Master’s degree in Bioengineering from University of California, San Diego.
Adam Barlett
Certification Project Manager and Product Reviewer, GMED North America
Adam is expert in product development and risk management for orthopedic medical devices. He has 8+ years experience in end to end medical device development, including time at Zimmer Biomet, for products sold around the world in various levels of complexity and regulatory pathways. Adam has been instrumental in the development of implants and instruments related to the treatment and alleviation of pain and reconstruction of joints for patients with hip, knee, extremity, sports medicine, and trauma needs.
Adam joined GMED in 2021 as a Certification Project Manager, guiding clients through the audit and technical file evaluation process for ISO 13485:2016, MDSAP, Medical Device Directive 93/42/EEC, and Medical Device Regulation 2017/745. Adam is also a qualified product reviewer for non-active orthopedic implants and non-active, non-implantable instruments undergoing MDR evaluation.
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
Check out the 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
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