Practical Application of Risk Management to Medical Devices Trainer: Mr. Vincent Cheung
The application of risk management to medical devices including software is a global regulatory requirement regardless of device classifications and when implemented effectively, manufacturers will be able to achieve regulatory compliance and effectively manage safety and security risks associated with their medical devices for the patients, clinicians, healthcare professionals, and other persons involved throughout the entire medical device life cycle. Trainees will learn the process of risk management that needs to be applied throughout a medical device life cycle in accordance with EN/ISO 14971:2019 with focus on “how-to” perform risk management planning, risk assessment, risk estimation, risk evaluation, risk control, and the evaluation of the overall residual risk. The collection and review of information in the production and post-production phase will be discussed. Trainees will also learn how to apply different risk analysis methods such as Preliminary Hazard Analysis (PHA), Failure Mode and Effects Analysis (FMEAs), and Software Hazard Analysis (SHA) to generate a comprehensive risk analysis and related documentation that meets regulatory requirements.
Day 1
Regulatory background (EN/ISO 14971)
Risk management process
Risk management planning
Risk assessment
Risk estimation
Risk evaluation
Risk controls
Residual risk evaluation
Preliminary Hazard Analysis
Design FMEA (group activity)
Day 2
Software Hazard Analysis
Application FMEA (group activity)
Process FMEA (if time permits)
Benefit-risk analysis
Risk management review
Any organizations or person(s) interested in bringing a new or modified medical device to market. Typical job functions include but not limited to:
NPI Engineers
Software Engineers
Quality (QMS, QA/QC, QE)
Manufacturing Engineers
Regulatory Affairs
Available Workshops:
Please contact AQS Labs.
Workshop Fee: