Postgraduate Diploma in Use Error Management and Mitigations
Online 800-hour Postgraduate Diploma in Use Error Management and Mitigations. 8 modules covering IEC 62366-1 (usability engineering), ISO 14971 (risk management for medical devices) and Jama Connect. Dedicated tutor and open enrolment.
Take the controls.
Run a real engineering trade-off from this field. Move the sliders, watch the model react in real time and beat the challenge.
What you will be able to do
Classify the types of use error in medical devices.
Identify use-related hazards through task analysis.
Estimate and evaluate use-related risk.
Apply the hierarchy of risk control measures.
Design interfaces that prevent use errors.
Verify the effectiveness of implemented mitigations.
Analyse post-market data to detect new use errors.
Who it's for
- Use risk engineer looking to specialise in Use Error Management and Mitigations.
- Human factors specialist looking to specialise in Use Error Management and Mitigations.
- Medical device interface designer looking to specialise in Use Error Management and Mitigations.
- Quality and regulatory engineer looking to specialise in Use Error Management and Mitigations.
- Post-market surveillance manager looking to specialise in Use Error Management and Mitigations.
- Patient safety consultant looking to specialise in Use Error Management and Mitigations.
- Graduates in engineering or sciences seeking to join medical device manufacturers.
What you'll work with
- IEC 62366-1 (usability engineering)
- ISO 14971 (risk management for medical devices)
- ISO/TR 24971 (application guide for ISO 14971)
- ANSI/AAMI HE75
- IEC 60601-1-6
- Regulation (EU) 2017/745 (medical devices)
- 21 CFR Part 820 (FDA quality system)
8 modules · 800 h
1.1Definition of use error in IEC 62366-11.2Abnormal use versus use error1.3Human error taxonomies1.4Perception, cognition and action errors1.5Design contribution to error1.6Recalls due to use errors1.7MAUDE databases and safety alerts1.8Clinical and economic impact1.9Patient safety culture1.10Practical case: analysis of infusion pump alerts
2.1Task analysis for error identification2.2PCA: perception, cognition and action2.3Use failure mode analysis (uFMEA)2.4Analysis of reasonably foreseeable misuse2.5Review of complaints and post-market data2.6Analysis of similar products2.7Hazardous use scenarios2.8Alarm interfaces and associated risks2.9Errors in labelling and instructions2.10Practice: uFMEA of a home pulse oximeter
3.1Severity of consequences3.2Probability of use errors3.3Use-related risk analysis (URRA)3.4Determination of critical tasks3.5Integration with ISO 149713.6Fault trees with human error3.7Human reliability: THERP and HEART3.8Acceptability of use risk3.9Documentation of the evaluation3.10Workshop: URRA of an auto-injector
4.1Inherently safe design4.2Protective measures in the device4.3Information for safety4.4Training as a control measure4.5Locking and confirmation functions4.6Alarm and warning design4.7Connector design and prevention of incorrect connections4.8ISO 80369 connector standards4.9Relative effectiveness of measures4.10Practical case: mitigations for incorrect connections
5.1Affordances and physical constraints5.2Mapping and feedback5.3Screen and menu design5.4Units of measurement and numerical formats5.5Colour and shape coding5.6Packaging and labelling design5.7Effective instructions for use5.8Interfaces for high-workload environments5.9IEC 60601-1-6 and IEC 60601-1-8 standards5.10Laboratory: redesign of an infusion pump screen
6.1Verification of implementation6.2Validation of effectiveness with users6.3Targeted training studies6.4Root cause analysis following validation6.5Iteration and new mitigations6.6Residual use risk6.7Benefit-risk analysis6.8Mitigation-test traceability6.9Communication to the notified body6.10Practice: mitigation traceability matrix
7.1Collection of real-world use data7.2Analysis of use error trends7.3Incident reporting and FSCA7.4Feedback from clinical users7.5Updating the usability file7.6Design changes after commercialisation7.7Training and safety communications7.8Use safety indicators7.9Coordination with risk management7.10Workshop: analysis of complaint trends
8.1Device selection8.2Task analysis8.3Identification of use errors8.4Risk evaluation8.5Design of mitigations8.6Verification and validation plan8.7Surveillance plan8.8Error management report8.9Report and presentation8.10Final review with the tutor
How you'll learn
Fully online training on the SEIUM campus, with downloadable material, recorded classes and a dedicated technical tutor. There are no fixed timetables: students progress at their own pace within the intake, allowing them to combine the programme with work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is Jama Connect, Greenlight Guru, advanced Excel, Figma, in free, academic or evaluation versions. Tests are studied using real procedures for critical task analysis, use failure mode analysis (uFMEA) and review of post-market surveillance reports. Assessment is continuous, module by module, plus the final integrative project.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Classify the types of use error in medical devices.
Identify use-related hazards through task analysis.
Estimate and evaluate use-related risk.
Apply the hierarchy of risk control measures.
Design interfaces that prevent use errors.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- Internet connection and a computer capable of running the programme's software.
- Sufficient level of Spanish to follow the reading of technical standards.
Ready to start?
Send your application today. Our admissions team replies within 72 hours with your study plan and funding options.
Frequently asked questions
The programme comprises 800 total hours spread over 6 to 8 months. That is between 10 and 15 hours per week on average, compatible with a full-time job.
You work with Jama Connect, Greenlight Guru, advanced Excel and Figma. Free, academic or evaluation versions are used, and the tutor indicates the free alternative where one exists.
A SEIUM diploma upon passing the continuous assessment and the integrative project. It is in-house training, not an official Ministry qualification.
Yes. Modules passed in a course or diploma in the same area are credited towards the advanced programme. Check the credit transfer policy when you enrol.
Related programmes
Postgraduate Diploma in Therapeutic Virtual Reality and Protocols
Online Postgraduate Diploma of 800 hours in Therapeutic Virtual Reality and Protocols. 8 modules covering Regulation (EU) 2017/745 (MDR), IEC 62304 (healthcare software lifecycle) and Unity.…
Postgraduate Diploma in TinyML: Quantisation, Pruning and On-Device Compilation
Online 800-hour Postgraduate Diploma in tinyML: Quantisation, Pruning and On-Device Compilation. 8 modules covering Regulation (EU) 2024/1689 (AI Act), Regulation (EU) 2024/2847 (Cyber Resilience Act) and…
Postgraduate Diploma in Service KPIs and Patient Experience
Online 800-hour Postgraduate Diploma in Service KPIs and Patient Experience. 8 modules with ISO 7101 (quality management in healthcare organisations), ISO 10004 (monitoring and measurement of…
More in Health, Biomechanics, Wearables & Operational Safety
All Health, Biomechanics, Wearables & Operational Safety programmes → · How to apply · Fees & financing · Scholarships