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Postgraduate DiplomaHealth, Biomechanics, Wearables & Operational Safety Applications open

Diploma in Workshop Network Operations: Times, Warranty and KPIs

Online postgraduate diploma of 800 hours in workshop network operations — labour times, warranty and KPIs. 8 modules covering fundamentals, the regulatory framework (MDR, ISO 13485, IEC 62304), analysis methods, design, systems integration, risk, validation and an integrative case study, with an assigned technical tutor.

Duration800 hours · 6–8 months
ModeOnline
LanguageEnglish
Start datesSet by the faculty
AwardSEIUM Institute diploma
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Learning outcomes

What you will be able to do

01

Master the technical fundamentals of workshop network operations — labour times, warranty and KPIs and their regulatory vocabulary.

02

Apply Regulation (EU) 2017/745 (MDR), ISO 13485 and IEC 62304 (medical device software) to real design and validation decisions.

03

Build and correlate calculation models with OpenSim and AnyBody Modeling System.

04

Plan and run test campaigns in a motion analysis laboratory and on an implant test bench.

05

Analyse operating data and turn it into engineering decisions.

06

Prepare the technical and compliance dossier required by the client or the regulator.

07

Lead a workshop network operations — labour times, warranty and KPIs project technically from start to finish.

Profile

Who it's for

  • Biomedical engineers who manage technical service networks for equipment.
  • Biomechanics specialists involved in after-sales technical support.
  • Healthcare regulatory affairs managers overseeing post-market service and warranty.
  • Medical software engineers developing service management and KPI tools.
  • Clinical trials technicians who coordinate field technical teams.
  • Orthosis and prosthesis designers running fitting and repair workshops.
  • Engineering or science graduates looking to enter the medical device sector.
Standards & tools

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
Syllabus

8 modules

  1. 1.1Fundamental concepts and quantities of Workshop Network Operations: Times, Warranty and KPIs
  2. 1.2Technological landscape and state of the art
  3. 1.3Technical terminology and reference documentation
  4. 1.4Physical and engineering principles applied to the case
  5. 1.5Functional architecture: from requirements to components
  6. 1.6Interfaces and dependencies with adjacent systems
  7. 1.7Typical use cases in the sector
  8. 1.8Common errors and how to detect them early
  9. 1.9Data sources and quality criteria
  10. 1.10Guided exercise: initial diagnosis
  1. 2.1Applicable regulatory framework: overview
  2. 2.2Regulatory hierarchy and conflicts between standards
  3. 2.3Mandatory requirements versus good practice
  4. 2.4Acceptance criteria and required evidence
  5. 2.5Technical documentation and traceability
  6. 2.6Change management and configuration control
  7. 2.7Audits, inspections and non-conformities
  8. 2.8Responsibilities and division of scope
  9. 2.9Interpretation of critical clauses
  10. 2.10Exercise: regulatory checklist
  1. 3.1Setting up the model: hypotheses and simplifications
  2. 3.2Selection of tools and working environment
  3. 3.3Preparation of input data
  4. 3.4Workflow and good modelling practice
  5. 3.5Discretisation and case preparation
  6. 3.6Boundary conditions and load cases
  7. 3.7Convergence control and numerical verification
  8. 3.8Sensitivity analysis and parametric study
  9. 3.9Automation and reuse of models
  10. 3.10Exercise: building a base model
  1. 4.1Design requirements and starting criteria
  2. 4.2Solution alternatives and comparative analysis
  3. 4.3Sizing and safety margins
  4. 4.4Selection of materials, equipment or components
  5. 4.5Integration with the rest of the system
  6. 4.6Cost, schedule and manufacturing constraints
  7. 4.7Reliability, maintainability and service life
  8. 4.8Sustainability and efficiency in design
  9. 4.9Design review and risk management
  10. 4.10Exercise: documented design proposal
  1. 5.1System architecture and functional breakdown
  2. 5.2Interface definition and control
  3. 5.3Protocols and data exchange
  4. 5.4Progressive integration and interface testing
  5. 5.5Electromagnetic and environmental compatibility
  6. 5.6Configuration management of the whole system
  7. 5.7Resolving conflicts between subsystems
  8. 5.8Tuning of the integrated system
  9. 5.9Traceability from requirements to verification
  10. 5.10Exercise: interface matrix
  1. 6.1Hazard identification and preliminary analysis
  2. 6.2Failure modes and effects analysis
  3. 6.3Fault trees and quantitative analysis
  4. 6.4Allocation of reliability targets
  5. 6.5Barriers, redundancy and fault tolerance
  6. 6.6Human factors and operating errors
  7. 6.7Safety evidence and argumentation
  8. 6.8Risk management throughout the life cycle
  9. 6.9Indicators and monitoring in operation
  10. 6.10Exercise: risk analysis of a case
  1. 7.1Verification and validation strategy
  2. 7.2Test plan: scope and coverage
  3. 7.3Instrumentation and data acquisition
  4. 7.4Laboratory testing versus field testing
  5. 7.5Correlation between model and measurement
  6. 7.6Handling uncertainty and tolerances
  7. 7.7Failure analysis and corrective actions
  8. 7.8Commissioning and acceptance criteria
  9. 7.9Documenting the validation file
  10. 7.10Exercise: validation report
  1. 8.1Definition of the case and success criteria
  2. 8.2Collection of input data and requirements
  3. 8.3Work planning and deliverables
  4. 8.4Technical development guided by the tutor
  5. 8.5Application of the regulatory framework to the case
  6. 8.6Verification of results and critical analysis
  7. 8.7Documentation of the deliverable
  8. 8.8Technical defence and peer review
  9. 8.9Lessons learned and continuous improvement
  10. 8.10Final project: final assessment and programme close-out
Methodology, software & labs

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 you can combine the programme with your job.

Each module combines theory, guided reading of the original standard and applied exercises. The working software is OpenSim, AnyBody Modeling System, Mimics, 3-matic and 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.

Assigned technical tutor:every module ends with a deliverable that your tutor marks individually.
Standards-based learning:guided reading of Regulation (EU) 2017/745 (MDR), ISO 13485 and IEC 62304 applied to real cases, not as a theoretical annex.
Industry software:OpenSim, AnyBody Modeling System, Mimics, 3-matic and ANSYS Mechanical, in free, academic or evaluation versions.
Final project:A complete operating model for a workshop network with labour times, warranty and KPIs, reviewed by your tutor.
Flexible format:100% online, no fixed timetables, compatible with full-time work.
Capstone project

Build it end to end

Your final project follows the real engineering workflow, step by step, reviewed by your tutor.

Initial diagnosis
Analyse the operation of a real workshop network and its main bottlenecks.
Regulatory checklist
Draw up the warranty and quality compliance checklist for the network.
Times and KPI model
Define standard labour times and the KPI dashboard for the workshops.
Warranty risk and validation
Analyse warranty costs and risks and validate the improvement measures.
Final project
Develop a complete operating plan for a workshop network, reviewed by your tutor.
Career opportunities

Where this takes you

Biomedical engineerBiomechanics specialistHealthcare regulatory affairs managerMedical software engineerClinical trials technicianOrthosis and prosthesis designer
Admissions & scholarships

Requirements

  • Prior technical training or professional experience in the sector. No university degree is required.
  • An internet connection and a computer able to run 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.

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FAQ

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 and 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), plus 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.

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