ISO 14971:2019 Medical Device Risk Course

Name: ISO 14971:2019 Medical Device Risk Management Course
Availability: InStock

Apply ISO 14971:2019 through lifecycle planning, hazard analysis, risk controls, residual-risk decisions, traceability, and post-production feedback.

ISO 14971:2019 Medical Device Risk Course

At a glance

Duration: 1 Week
Format: Classroom
Cities: Nice, Trabzon, Jakarta, Dubai, Munich, Kuwait and more
Next session: 2 – 6 November 2026, Nice
Average fee: 5,750 €

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ISO 14971:2019 Medical Device Risk Management Course

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Overview

ISO 14971:2019 Medical Device Risk Management Course is a one-week advanced course for medical device quality, regulatory, engineering, clinical, manufacturing, supplier, and risk personnel, who leave with an ISO 14971 Risk Management File Pack. The course connects planning, intended use, hazards, hazardous situations, estimation, evaluation, controls, residual risk, benefit-risk, review, traceability, and production and post-production feedback. Agile Leaders Training Center presents ISO 14971:2019 application across the medical device lifecycle.

Who Should Attend

Teams responsible for medical device risk-management systems
Personnel responsible for design and product safety engineering
Functions responsible for quality and regulatory documentation
Teams responsible for manufacturing, supplier, and change interfaces
Personnel responsible for complaint, vigilance, and post-production feedback

The course assumes experience with medical device development or quality work and leaves out certification, clinical decision-making, and jurisdiction-specific regulatory approval advice.

Departments and Industries

The course supports organizations that develop, manufacture, supply, or maintain medical devices and related software.

Medical device and diagnostic product manufacturers
Software as a medical device organizations
Design, engineering, and product-development teams
Quality, regulatory, clinical, and safety functions
Contract manufacturing and critical supplier organizations

Learning Objectives

By the end of this course, participants will be able to:

Apply ISO 14971:2019 terminology and lifecycle process
Build risk plans and objective acceptability criteria
Analyze hazards, event sequences, and hazardous situations
Evaluate risk-control options and residual risks
Use benefit-risk and overall residual-risk methods
Integrate production and post-production information

Course Agenda

Day 1: Risk Management System and Planning

ISO 14971:2019 Lifecycle Process Map
Risk Management Policy and Responsibility Matrix
Risk Management Plan Structure
Objective Risk Acceptability Criteria
Risk Management File Traceability Index

Day 2: Risk Analysis and Estimation

Intended Use and Reasonably Foreseeable Misuse Statement
Safety-Related Characteristics Checklist
Hazard and Hazardous Situation Identification Map
Foreseeable Sequence of Events Model
Severity and Probability Estimation Record

Day 3: Risk Evaluation and Control

Risk Evaluation Decision Matrix
Inherent Safety, Protective Measure, and Information Hierarchy
Risk Control Option Analysis
Control Implementation and Verification Evidence
Residual Risk and Introduced Risk Review

Day 4: Benefit-Risk, Review, and Feedback

Individual Benefit-Risk Analysis Record
Overall Residual Risk Evaluation Method
Risk Management Review and Report Checklist
Production and Post-Production Information Plan
Feedback, Change, and Risk Reassessment Loop

Day 5: ISO 14971 Application Practice

Suggested Exercise: Risk Plan and Criteria Review
Suggested Exercise: Hazardous Situation Analysis
Suggested Exercise: Control and Residual Risk Decisions
Suggested Exercise: Post-Production Reassessment
Capstone Exercise: ISO 14971 Risk Management File Pack

Practical Exercises

The course uses suggested activities with fictional electrical, software, diagnostic, reusable, and home-use medical device scenarios.

Suggested activity: establish a risk plan, responsibilities, criteria, and file index.
Suggested activity: map hazards, event sequences, hazardous situations, harms, and estimates.
Suggested activity: select controls, verify implementation, and evaluate residual and introduced risks.
Suggested activity: review production information and document whether reassessment is necessary.

FAQs

Who suits ISO 14971:2019 medical device risk management training, and what does it assume?

Medical device quality, regulatory, engineering, clinical, manufacturing, supplier, and risk personnel suit the course; it assumes experience with product-development or quality processes.

How does ISO 14971:2019 risk management differ from general enterprise risk training?

ISO 14971:2019 addresses risks associated with medical devices across their lifecycle, including hazardous situations, harm, controls, residual risk, benefit-risk, and production feedback rather than financial or strategic business risk.

What belongs in an ISO 14971:2019 risk management file?

An ISO 14971 risk management file should provide traceability to the plan, analysis, evaluation, controls, verification, residual-risk decisions, benefit-risk work, overall evaluation, review, report, and production and post-production activities.

When is medical device risk reassessment needed?

Risk reassessment is needed when production, complaints, vigilance, service, usability, cybersecurity, supplier, change, scientific, or field information indicates new hazards, changed estimates, affected controls, or altered benefit-risk conclusions.

Conclusion

Participants leave with an ISO 14971 Risk Management File Pack containing policy, plan, criteria, hazard, estimation, control, verification, benefit-risk, review, feedback, and traceability tools. The pack turns the standard's lifecycle process into connected records and decisions. It helps teams maintain risk evidence as device knowledge changes.

credits: 5 credit per day

Course Mode: full-time

Provider: Agile Leaders Training Center

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Showing 61-75 of 75 events

Location	Dates	Duration	Mode	Price
Baku	Week 33, 2027 16 – 20 August 2027	1 Week	Onsite	€5,000
Abu Dhabi	Week 34, 2027 23 – 27 August 2027	1 Week	Onsite	€4,700
Bali	Week 34, 2027 29 August – 2 September 2027	1 Week	Onsite	€5,700
Istanbul	Week 35, 2027 30 August – 3 September 2027	1 Week	Onsite	€4,500
Manama	Week 35, 2027 5 – 9 September 2027	1 Week	Onsite	€4,700
Dubai	Week 37, 2027 13 – 17 September 2027	1 Week	Onsite	€4,500
Singapore	Week 37, 2027 13 – 17 September 2027	1 Week	Onsite	€5,700
Barcelona	Week 38, 2027 20 – 24 September 2027	1 Week	Onsite	€5,700
Prague	Week 38, 2027 20 – 24 September 2027	1 Week	Onsite	€6,000
Milan	Week 39, 2027 27 September – 1 October 2027	1 Week	Onsite	€5,700
Berlin	Week 40, 2027 4 – 8 October 2027	1 Week	Onsite	€5,700
Bangkok	Week 40, 2027 10 – 14 October 2027	1 Week	Onsite	€6,000
Chicago	Week 41, 2027 17 – 21 October 2027	1 Week	Onsite	€12,000
Cairo	Week 42, 2027 18 – 22 October 2027	1 Week	Onsite	€4,100
Johannesburg	Week 42, 2027 24 – 28 October 2027	1 Week	Onsite	€4,500

Frequently asked questions

What does this course cover?

OverviewISO 14971:2019 Medical Device Risk Management Course is a one-week advanced course for medical device quality, regulatory, engineering, clinical, manufacturing, supplier, and risk personnel, who leave with an ISO 14971 Risk Management File Pack. The course connects planning, intended use, hazards, hazardous situations, estimation, evaluation, cont…

Are training dates available?

Yes. Available dates and destinations are listed in the course dates section on this page.

How can I register?

Choose an available date on this page and complete the registration form, or send a programme enquiry.

Can I download the course brochure?

Yes. Use the brochure download link provided on this page.

ISO 14971:2019 Medical Device Risk Course