Who it’s for
Who should attend
Design and development engineers, risk managers and risk file owners, quality and regulatory affairs staff, project managers, and clinical or marketing staff who contribute to intended use and use-related risk.
Curriculum
Course modules
- Scope, terms and the relationship with ISO/TR 24971 guidance
- Clause 4, General requirements: risk management process, management responsibilities, competence, risk management plan, risk management file
- Clause 5, Risk analysis: intended use and reasonably foreseeable misuse, safety characteristics, identification of hazards and hazardous situations, risk estimation
- Clause 6: Risk evaluation and risk acceptability criteria
- Clause 7, Risk control: option analysis and priority order, implementation, residual risk evaluation, benefit-risk analysis, risks arising from control measures, completeness of risk control
- Clause 8: Evaluation of overall residual risk
- Clause 9: Risk management review and the risk management report
- Clause 10: Production and post-production activities, information collection, review and actions
- Interfaces with ISO 13485, IEC 62366-1, IEC 62304 and IEC 60601-1
- Common regulator and notified body findings
Outcomes
What you’ll be able to do
- Build and maintain a compliant risk management file
- Distinguish hazard, hazardous situation, harm and risk in practice
- Perform and document a benefit-risk analysis
How it works
Delivery, group size and what’s included
Delivery formats
On-site at your premises, live remote, or public open course.
Duration
The durations shown are minimums. Most courses run from 2 to 5 days, and longer or combined programmes can be arranged to suit the course and your requirements.
Group size
No minimum for remote or private on-site training. Public courses run with a minimum of 10 attendees. There is no fixed maximum; above 20 we normally split into groups, though this is open to discussion.
Assessment
Courses include an assessment.
Tailoring
Private training can be tailored to your products and your quality system. Where a course is tailored, specific documents may be requested in advance. Public courses are general in scope, though relevant worked examples are provided.
Languages
English and Italian. German and Russian available on request through an associate.
Included in the fee
- Full course slides (PDF)
- Workshops
- Practical exercises
- Case studies
- Open Q&A throughout
- Certificate of attendance (PDF), issued by ALPA Medical
- Up to 4 hours of post-course support
Get in touch
Enquire about “Risk Management for Medical Devices”
Ask about dates, on-site or remote delivery, group size, or tailoring this course to your products and quality system.