ISO 14971 Risk Management Training
Practical Medical Device Risk Management Training
Patient Guard’s ISO 14971 Risk Management Training course provides a practical introduction to medical device risk management principles and the requirements of ISO 14971:2019.
This course is designed to help manufacturers understand how to identify hazards, evaluate risks, implement risk controls and maintain effective risk management processes throughout the entire medical device lifecycle.
Our training combines regulatory expectations with practical industry examples to support organisations developing, manufacturing or maintaining medical devices.
Course Overview
ISO 14971 is the internationally recognised standard for the application of risk management to medical devices. Effective risk management is a core requirement under EU MDR, UK MDR and global regulatory frameworks.
This training course provides participants with a clear understanding of practical regulatory expectations and core methodologies to help organisations strengthen compliance and improve overall product safety.
- Risk management terminology
- Risk analysis methodologies
- Hazard identification
- Risk evaluation and acceptability
- Risk control implementation
- Benefit-risk analysis
- Residual risk evaluation
- Production and post-production activities
- Risk management documentation
Who Should Attend?
This course is tailored specifically for the following roles and teams:
- Medical device manufacturers
- QA/RA professionals
- Design and development engineers
- Project managers
- Start-up companies
- Product development teams
- Compliance professionals
- Individuals new to ISO 14971
What You Will Learn
By the end of this course, participants will understand:
- The structure and purpose of ISO 14971:2019
- How risk management applies throughout the device lifecycle
- How to identify hazards and hazardous situations
- Methods for estimating and evaluating risk
- How to establish risk acceptability criteria
- How to implement and verify risk controls
- How to perform benefit-risk analysis
- How post-market information feeds into risk management
- Regulatory expectations under EU MDR and UK MDR
- The relationship between ISO 14971 and IEC/TR 24971
Course Topics
Introduction to Risk Management
- Risk management principles
- Regulatory expectations
- Lifecycle approach
ISO 14971 Structure & Requirements
- Key clauses of ISO 14971
- Scope and application
- Definitions and terminology
Risk Analysis
- Intended use and reasonably foreseeable misuse
- Hazard identification
- Hazardous situations
- Sequence of events
- Risk estimation methods
Risk Evaluation
- Risk acceptability
- Severity and probability assessment
- Risk matrices and scoring approaches
Risk Control
- Inherent safety by design
- Protective measures
- Information for safety
- Verification of controls
Benefit-Risk Analysis
- Evaluating residual risks
- Acceptability decisions
Production & Post-Production
- Complaint handling
- Vigilance and PMS feedback
- Updating the risk management file
Risk Management Files
- Risk management plans
- Risk management reports
- Maintaining the risk management file
.
Why Choose Patient Guard?
Individual Training Options
Half-Day Training Course
- Live online instructor-led training
- Training materials
- Certificate of Attendance
- Opportunity for Q&A with the trainer
Full-Day Training Workshop
- Extended practical workshop sessions
- Real-world risk management examples
- Interactive discussions
- Training materials
- Certificate of Attendance
Corporate & Private Team Training
Patient Guard provides bespoke private training sessions explicitly tailored to your organisation’s devices, technologies, and internal Quality Management System (QMS) processes.
- Medical device manufacturers
- Start-ups and innovators
- Internal QA/RA teams
- Design and development teams
- Organisations implementing ISO 14971
- Total number of attendees
- Required training duration lengths
- Specific technical customisation pathways
- Preferred interactive delivery format
Delivery Format
All sessions are formatted for maximum interaction and accessibility:
- Live online & instructor-led
- Fully interactive and practical modules
- Available globally across international time zones
Custom on-site or dedicated corporate physical venue sessions are optionally available upon request.
Group Discounts
Do you have multiple attendees looking to sit the course from the same organisation?
Discounted tier scaling options are available for unified corporate team bookings.
Please reach out to Patient Guard directly for group booking pricing structures.
Request Pricing & Availability
Get in touch to check upcoming open course schedules, secure corporate group dates, or request an explicit customized quote for your team.
Contact Patient GuardIndividual Training Options
Half-Day Training Course
- Live online instructor-led training
- Training materials
- Certificate of Attendance
- Opportunity for Q&A with the trainer
Full-Day Training Workshop
- Extended practical workshop sessions
- Real-world risk management examples
- Interactive discussions
- Training materials
- Certificate of Attendance
Corporate & Private Team Training
Patient Guard provides bespoke private training sessions explicitly tailored to your organisation’s devices, technologies, and internal Quality Management System (QMS) processes.
- Medical device manufacturers
- Start-ups and innovators
- Internal QA/RA teams
- Design and development teams
- Organisations implementing ISO 14971
- Total number of attendees
- Required training duration lengths
- Specific technical customisation pathways
- Preferred interactive delivery format
Delivery Format
All sessions are formatted for maximum interaction and accessibility:
- Live online & instructor-led
- Fully interactive and practical modules
- Available globally across international time zones
Custom on-site or dedicated corporate physical venue sessions are optionally available upon request.
Group Discounts
Do you have multiple attendees looking to sit the course from the same organisation?
Discounted tier scaling options are available for unified corporate team bookings.
Please reach out to Patient Guard directly for group booking pricing structures.
Request Pricing & Availability
Get in touch to check upcoming open course schedules, secure corporate group dates, or request an explicit customized quote for your team.
Contact Patient GuardFAQs
Is this course suitable for beginners?
Yes. The course is designed to support both beginners and experienced professionals involved in medical device risk management.
Does the course cover EU MDR requirements?
Yes. The course explains how ISO 14971 supports compliance with EU MDR and UK MDR risk management expectations.
Is this training live or recorded?
Training is currently delivered live online with instructor support. Private sessions can also be arranged.
Can training be customised for our company?
Yes. Patient Guard can provide customised private training tailored to your devices, technologies and internal processes.
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