Diploma in OEE, SMED and Process Stability
Online postgraduate diploma of 800 hours in OEE, SMED and process stability. 8 modules covering fundamentals, the regulatory framework (Regulation (EU) 2017/745 (MDR), ISO 13485), analysis methods with OpenSim, design and sizing, systems integration, risk management, validation and an integrative case study, with an assigned technical tutor.
Diploma in OEE, SMED and Process Stability — studying from Canada
Canada has a well-developed health technology and medical device sector, with concentrations in Ontario, Québec, Alberta and British Columbia. Research institutions and hospitals collaborate with companies on biomechanics, rehabilitation engineering and wearable sensing. Medical devices are regulated by Health Canada under the Medical Devices Regulations, and workplace safety is overseen by provincial occupational health and safety bodies. Engineers in this field contribute to device development, ergonomics and operational safety assessment.
Fees for Canada: C$1,700 (Canadian dollar), with instalments and employer sponsorship available.
Relevant bodies in Canada
Typical roles
Questions from Canada
Is this programme recognised by professional bodies in Canada for engineering work in health and biomechanics?
SEIUM's qualifications are private qualifications, not official state degrees, and are not accredited by any national body in Canada. Professional engineering in Canada is regulated provincially by bodies such as Professional Engineers Ontario or Engineers and Geoscientists BC, which set licensing requirements. Recognition of a private qualification is decided by employers or the relevant body, so you should check directly with them before relying on it.
Will this qualification help me find work in biomechanics or wearables in Canada?
It can strengthen your technical profile, but employers in Canada, including hospitals, medical device firms and safety-focused companies, decide how much weight to give a private qualification. Many roles in regulated health technology also require provincial licensing or specific credentials. A final project and an assigned technical tutor can help you show practical capability in interviews, but no job outcome can be guaranteed.
Can I study this while working full time in Canada, and do I need a visa?
The programme is 100% online and taught in English, so you can study from home and no student visa is needed. Specialist courses are about 300 hours, postgraduate diplomas 800 hours and master's programmes 1,900 hours, so plan your weekly study time accordingly. Fees are payable in instalments, and employer sponsorship is possible. Check the time zone for live elements with the school before enrolling.
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
Master the technical fundamentals of OEE, SMED and process stability and the associated regulatory vocabulary.
Apply Regulation (EU) 2017/745 (MDR), ISO 13485 and IEC 62304 to real design and validation decisions.
Build and correlate calculation models with OpenSim and AnyBody Modeling System.
Plan and run test campaigns in a motion analysis laboratory and on an implant test bench.
Analyse operating data and translate it into engineering decisions.
Prepare the technical and compliance dossier required by the client or the regulator.
Lead an OEE, SMED and process stability project technically from start to finish.
Who it's for
- Biomedical engineers looking to specialise in OEE, SMED and process stability.
- Biomechanics specialists who want to add OEE, SMED and process stability to their skill set.
- Healthcare regulatory affairs managers who need a solid technical grounding in OEE, SMED and process stability.
- Medical software engineers moving into OEE, SMED and process stability projects.
- Clinical trials technicians who want to broaden their technical profile.
- Orthotics and prosthetics designers seeking to lead OEE, SMED and process stability work in their organisation.
- Engineering or science graduates looking to enter the medical devices sector.
What you'll work with
- Regulation (EU) 2017/745 (MDR) (EU Medical Device Regulation)
- ISO 13485 (quality management for medical devices)
- IEC 62304 (medical device software life cycle)
- ISO 14971 (risk management for medical devices)
- IEC 60601 (safety of medical electrical equipment)
- ISO 10993 (biological evaluation and biocompatibility)
- ISO 14155 (clinical investigation of medical devices)
- Regulation (EU) 2016/679 (GDPR, personal data protection)
- UNE-EN ISO 22442 (medical devices utilising animal tissues)
- OpenSim
- AnyBody Modeling System
- Mimics
- 3-matic
- ANSYS Mechanical
8 modules
1.1Core concepts and quantities of OEE, SMED and Process Stability1.2Technology landscape and state of the art1.3Technical terminology and reference documentation1.4Physical and engineering principles applied to the case1.5Functional architecture: from requirements to components1.6Interfaces and dependencies with adjacent systems1.7Typical use cases in the sector1.8Common errors and how to detect them early1.9Data sources and quality criteria1.10Guided exercise: initial diagnosis
2.1Applicable regulatory framework: overview2.2Regulatory hierarchy and conflicts between standards2.3Mandatory requirements versus good practice2.4Acceptance criteria and required evidence2.5Technical documentation and traceability2.6Change management and configuration control2.7Audits, inspections and non-conformities2.8Responsibilities and division of scope2.9Interpretation of critical clauses2.10Exercise: regulatory checklist
3.1Setting up the model: assumptions and simplifications3.2Selection of tools and working environment3.3Preparation of input data3.4Workflow and good modelling practice3.5Discretisation and case preparation3.6Boundary conditions and load cases3.7Convergence control and numerical verification3.8Sensitivity analysis and parametric study3.9Automation and model reuse3.10Exercise: building a base model
4.1Design requirements and starting criteria4.2Solution alternatives and comparative analysis4.3Sizing and safety margins4.4Selection of materials, equipment or components4.5Integration with the rest of the system4.6Cost, schedule and manufacturing constraints4.7Reliability, maintainability and service life4.8Sustainability and efficiency in design4.9Design review and risk management4.10Exercise: documented design proposal
5.1System architecture and functional breakdown5.2Interface definition and control5.3Protocols and data exchange5.4Progressive integration and interface testing5.5Electromagnetic and environmental compatibility5.6Configuration management of the whole system5.7Resolving conflicts between subsystems5.8Commissioning the integrated system5.9Traceability from requirements to verification5.10Exercise: interface matrix
6.1Hazard identification and preliminary analysis6.2Failure modes and effects analysis6.3Fault trees and quantitative analysis6.4Allocation of reliability targets6.5Barriers, redundancy and fault tolerance6.6Human factors and operating errors6.7Safety evidence and argumentation6.8Risk management throughout the life cycle6.9Indicators and monitoring in operation6.10Exercise: risk analysis of a case
7.1Verification and validation strategy7.2Test plan: scope and coverage7.3Instrumentation and data acquisition7.4Laboratory testing versus field testing7.5Correlation between model and measurement7.6Treatment of uncertainty and tolerances7.7Failure analysis and corrective actions7.8Commissioning and acceptance criteria7.9Documentation of the validation file7.10Exercise: validation report
8.1Definition of the case and success criteria8.2Collection of input data and requirements8.3Work planning and deliverables8.4Technical development guided by the tutor8.5Application of the regulatory framework to the case8.6Verification of results and critical analysis8.7Documentation of the deliverable8.8Technical defence and peer review8.9Lessons learned and continuous improvement8.10Final project: final assessment and programme close-out
How you'll learn
100% online training on the SEIUM campus, with downloadable material, recorded classes and an assigned technical tutor. There are no fixed timetables: you progress at your own pace within each intake, so it is compatible with full-time work.
Each module combines theory, guided reading of the original standard and applied exercises. The working software is OpenSim, AnyBody Modeling System, Mimics, 3-matic, ANSYS Mechanical, in free, academic or evaluation versions. Testing is studied on real procedures from a motion analysis laboratory, an implant test bench and a biocompatibility chamber. Assessment is continuous by module plus the final integrative project.
Standards covered: Regulation (EU) 2017/745 (MDR), ISO 13485, IEC 62304, ISO 14971, IEC 60601, ISO 10993, ISO 14155, Regulation (EU) 2016/679, UNE-EN ISO 22442.
Build it end to end
Your final project follows the real engineering workflow, step by step, reviewed by your tutor.
Where this takes you
Requirements
- Prior technical training or professional experience in the sector. No university degree is required.
- An internet connection and a computer capable of running the programme software.
- English sufficient to read 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 totals 800 hours over 6–8 months. You set your own pace within each intake, and your tutor helps you plan the workload around your job.
You work with OpenSim, AnyBody Modeling System, Mimics, 3-matic, ANSYS Mechanical, using free, academic or evaluation versions. Your tutor indicates the free alternative wherever one exists.
A SEIUM Institute diploma, awarded on passing the continuous assessment and the final project. It is SEIUM's own qualification, not an official state degree; its recognition depends on the programme completed and the regulations of each country.
Yes. Modules passed are recognised in a higher programme in the same area (postgraduate diploma or master's). Ask about the recognition policy when you enrol.
Prior technical training or professional experience in the sector (no university degree is required), a computer able to run the programme software and English sufficient to read technical standards.
Start dates are set by SEIUM's faculty for each intake. Our admissions team will confirm the next available date when you apply.
Related programmes
Postgraduate Diploma in Formative and Summative Assessments
Online 800-hour Postgraduate Diploma in Formative and Summative Assessments. 8 modules covering IEC 62366-1 (usability engineering for medical devices), IEC/TR 62366-2 and Tobii Pro Lab. Assigned…
Postgraduate Diploma in Outcome Validation and Patient Follow-Up
Online 800-hour Postgraduate Diploma in Outcome Validation and Patient Follow-Up. 8 modules covering ISO 14155 (clinical investigation of medical devices), Regulation (EU) 2017/745 (medical devices), and…
Postgraduate Diploma in Mechanical Shock, Transport and Operator Protection
Online 800-hour Postgraduate Diploma in Mechanical Shock, Transport and Operator Protection. 8 modules covering ISTA 3A (parcel shipment testing), ASTM D4169 (performance testing of shipping containers)…
More in Health, Biomechanics, Wearables & Operational Safety
All Health, Biomechanics, Wearables & Operational Safety programmes → · How to apply · Fees & financing · Scholarships