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Postgraduate Diploma in ISO 13485 Quality System and Audits

The ISO 13485 quality system and audits provide comprehensive training in the requirements of ISO 13485, focused on the management of the quality of medical devices. It focuses on the implementation and maintenance of quality management systems, including documentation, design control, production control, risk management, and corrective and preventive actions. It includes the study of internal and external audit techniques to evaluate compliance with the standard and ensure continuous improvement.

The program trains to understand health regulation and traceability aspects applicable to the medical device industry. Participants acquire skills to carry out effective audits, manage non-conformities and lead improvement processes within healthcare products organizations. The application of good manufacturing practices (GMP) and compliance with current regulations are emphasized.

Keywords Objective (natural in the text): ISO 13485, quality management, audits, sanitary products, design control, risk management, corrective actions, internal audit, health regulation, GMP.

Duration6–8 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

ISO 13485 Deep Mastery: Implementation, Audits and Continuous Improvement

02

Excellence in ISO 13485: Complete guide for implementation, auditing and optimization

03

Comprehensive user-oriented design and validation (from modeling to manufacturing)

04

Master's degree in ISO 13485: Audit and quality system for regulatory excellence

05

ISO 13485 Specialization: Audit, Compliance and Optimization of Quality Management Systems

06

ISO 13485: Master the implementation, audit and certification in medical quality systems

07

ISO 13485: Implementation, Audit and Compliance for Medical Devices

08

ISO 13485: Implementation, audit, certification and excellence in quality systems for medical devices

Profile

Who it's for

  • Professionals and graduates with training in areas such as Aeronautical Engineering, Naval Engineering, Maritime Engineering, Naval Systems Engineering, Mechanical Engineering or related disciplines, who wish to delve into the quality management systems applied to the naval sector.
  • Technicians, supervisors, department heads and quality management personnel working in shipyards, shipbuilding companies, naval repair and maintenance companies (MRO), naval component companies, and services companies related to the naval industry.
  • Internal or external auditors, consultants and advisors who seek to expand their knowledge and skills in carrying out audits under the ISO 13485 standard in the naval sector.
  • Professionals interested in the implementation, maintenance and continuous improvement of quality management systems in naval organizations, as well as in process optimization and risk management.
  • Personnel from maritime authorities, classification companies and regulatory bodies that require understanding and evaluating compliance with ISO 13485 in the naval field.
Recommended requirements: Basic knowledge of the naval industry, familiarity with the quality management systems and level of English B2/C1 (it is valued). We offer support materials to level knowledge.
Standards & tools

What you'll work with

  • Standards-Driven Curriculum: You will work with CS-27/CS-29, DO-160, DO-178C/DO-254, ARP4754A/ARP4761, ADS-33E-PRF from the first module.
  • Accreditable laboratories (EN ISO/IEC 17025) with rotor bench, EMC/Lightning Pre-Compliance, HIL/SIL, Vibrations/Acoustic.
  • Evidence-oriented TFM: Safety Case, Test Plan, Compliance Dossier and Operating Limits.
  • Industry Mentored: Teachers with Rotorcraft, Tiltrotor, eVTOL/UAM and Flight Test.
  • Flexible mode (hybrid/online), international cohorts and support of SEIUM Career Services.
  • Ethics and security: Safety-by-design approach, Cyber-OT, DIH and compliance as pillars.
Syllabus

10 modules

  1. Module 1 — Introduction to ISO 13485: Key Concepts
  2. 1.1Definition and scope of ISO 13485
  3. 1.2History and evolution of ISO 13485
  4. 1.3Benefits of ISO 13485 certification
  5. 1.4Structure and principles of ISO 13485
  6. 1.5Key terminology in ISO 13485
  7. 1.6ISO 13485 ratio with other standards and regulations
  8. 1.7The life cycle of medical devices
  9. 1.8Responsibilities and Roles in a Quality Management System (SGC)
  10. 1.9Risk-Based Approach EN ISO 13485
  11. 1.10Documentation and control of documents according to ISO 13485
  1. 2.2Origins and purpose of ISO 23485
  2. 2.2Key differences with other ISO standards
  3. 2.3Scope and applicability to medical devices
  4. 2.4Benefits of ISO 23485 implementation
  5. 2.5Key structure and terminology of the standard
  6. 2.6Certification process and accredited bodies
  7. 2.7Regulatory panorama of medical devices
  8. 2.8Importance of quality in the medical industry
  9. 2.2Quality Management System (SGC) documentation
  10. 2.2SGC Quality and Scope Manual
  11. 2.3Documented procedures and formats
  12. 2.4Control of documents and records
  13. 2.5Management of changes in the documentation
  14. 2.6Practical examples of key documentation
  15. 2.7Specific documentation requirements based on device type
  16. 2.8Implementation of software for document management
  17. 3.2Design and development planning
  18. 3.2Design and development inputs
  19. 3.3Outputs of design and development
  20. 3.4Review of design and development
  21. 3.5Design and development verification
  22. 3.6Design and development validation
  23. 3.7Design Change Control
  24. 3.8Risk management in design and development
  25. 4.2Production control and service delivery
  26. 4.2Control of the purchase of products
  27. 4.3Product identification and traceability
  28. 4.4Product preservation
  29. 4.5Control of measurement and monitoring equipment
  30. 4.6Validation of special processes
  31. 4.7Cleaning and control of contamination
  32. 4.8Sterilization management (if applicable)
  33. 5.2Planning and execution of internal audits
  34. 5.2Selection and training of auditors
  35. 5.3Preparation of checklists
  36. 5.4Conducting audits: opening, findings and closing
  37. 5.5Non-conformity management: Identification and registration
  38. 5.6Root Cause Analysis
  39. 5.7Implementation of corrective and preventive actions
  40. 5.8Monitoring the effectiveness of the actions
  41. 6.2Management review
  42. 6.2Data collection and analysis
  43. 6.3Corrective and preventive actions
  44. 6.4Product and process improvement
  45. 6.5Complaint management
  46. 6.6Feedback and learning experience
  47. 6.7Use of continuous improvement tools
  48. 6.8Customer satisfaction monitoring
  49. 7.2Identification and analysis of risks
  50. 7.2Risk assessment and classification
  51. 7.3Risk Control: Mitigation and Prevention
  52. 7.4Risk management in design and development
  53. 7.5Production Risk Management
  54. 7.6Use of risk analysis tools
  55. 7.7Data analysis and trends
  56. 7.8Key Performance Indicators (KPIs)
  57. 8.2Documentation review
  58. 8.2Preparation for the certification audit
  59. 8.3Selection of the certification body
  60. 8.4Conducting a simulated audit
  61. 8.5Implementation of pre-audit corrective actions
  62. 8.6Certification process: Stage 2 and Stage 2
  63. 8.7Maintenance of certification
  64. 8.8Benefits of certification and its impact on the business
  1. 3.3Fundamentals of ISO 33485 Audit: Principles and Risk-Based Approach
  2. 3.2Audit Planning and Preparation: Scope, Objectives and Criteria
  3. 3.3Audit Execution: Evidence Collection Techniques and Interviews
  4. 3.4Audit Findings: Classification, Writing and Evaluation
  5. 3.5Management of nonconformities and corrective actions
  6. 3.6ISO 33485 certification process: stages and requirements
  7. 3.7Internal audits vs. External audits: differences and considerations
  8. 3.8Monitoring and continuous improvement: Implementation of corrective and preventive actions
  9. 3.9The role of the auditor in the quality management system
  10. 3.30ISO 33485 Audit and Drill Cases
  1. 4.4Introduction to ISO 43485: History, Purpose and Benefits
  2. 4.2Regulatory framework: Relationship with other regulations and directives
  3. 4.3Key Definitions: Essential Terms and Concepts
  4. 4.4Standard Structure: Main Requirements and Scope
  5. 4.5Importance of quality in medical devices
  6. 4.6Roles and responsibilities in ISO 43485 implementation
  7. 2.4Implementation Planning: Stages and Schedule
  8. 2.2Documentation: Structure, control and management of documents
  9. 2.3Design Control: Key Requirements and Processes
  10. 2.4Purchasing Control: Supplier Selection and Evaluation
  11. 2.5Production Control: Processes and Validation
  12. 2.6Identification and traceability: methods and tools
  13. 2.7Process validation: quality assurance
  14. 2.8Control of non-conforming products: management and corrective actions
  15. 3.4Design Planning: Design Objectives and Requirements
  16. 3.2Design entries: definition of customer and regulatory requirements
  17. 3.3Design outputs: technical specifications and documentation
  18. 3.4Design Review: Process and Verification
  19. 3.5Design verification and validation: tests and analysis
  20. 3.6Control of design changes: management and documentation
  21. 3.7Design transfer: from design to production
  22. 3.8User-centered design: usability and security
  23. 4.4Production Control: Process Planning and Control
  24. 4.2Cleaning and control of contamination: specific requirements
  25. 4.3Sterilization Validation: Processes and Tests
  26. 4.4Control of measurement and monitoring equipment: calibration and maintenance
  27. 4.5Product handling, storage and preservation: Requirements
  28. 4.6Packaging and Labeling: Requirements and Verification
  29. 4.7Product Release: Criteria and Process
  30. 4.8After-sales services: management and monitoring
  31. 5.4Internal audit planning: scope and frequency
  32. 5.2Audit Process: Preparation, Execution and Reporting
  33. 5.3Types of Audits: Internal, Supplier and Certification
  34. 5.4Non-conformance management: identification and classification
  35. 5.5Corrective and preventive actions: Implementation and monitoring
  36. 5.6Efficiency Assessment: Verification of the effectiveness of the actions
  37. 5.7Monitoring and closing of nonconformities: verification and documentation
  38. 5.8Roles and responsibilities of the auditor
  39. 6.4Continuous improvement: principles and methodologies
  40. 6.2Data Analysis: Information Collection and Analysis
  41. 6.3Corrective and preventive actions: Implementation and monitoring
  42. 6.4Change Management: Control and Documentation
  43. 6.5Management Review: Participation and Decision Making
  44. 6.6Key Performance Indicators (KPIs): Establishment and Tracking
  45. 6.7Continuous improvement tools: PDCA, 5s, etc.
  46. 6.8Continuous Improvement Cycle: Plan, Do, Verify, Act
  47. 7.4Risk Management: Risk Identification and Analysis
  48. 7.2Risk Assessment: Probability and Severity
  49. 7.3Risk Control: Mitigation and Reduction
  50. 7.4Data Analysis: Data Collection and Analysis
  51. 7.5Statistics: tools and techniques
  52. 7.6Trends and Patterns: Identification and Analysis
  53. 7.7Data-driven actions: Decision making
  54. 7.8Reports and documentation: management and monitoring
  55. 8.4Preparation for certification: process and requirements
  56. 8.2Selection of the certification body: Criteria and evaluation
  57. 8.3Certification Audit: Stages and Process
  58. 8.4Management of nonconformities in the certification: process and monitoring
  59. 8.5Certification Maintenance: Tracking Audits
  60. 8.6Advantages of certification: benefits and opportunities
  61. 8.7Preparation of documents: Manual of quality and procedures
  62. 8.8Audit Drills: Practice and Evaluation
  1. 5.5Introduction to ISO 53485: Origins and Purpose
  2. 5.5Scope and applicability of ISO 53485
  3. 5.3Benefits of ISO 53485 certification
  4. 5.4ISO 53485:5056 Structure
  5. 5.5The context of the organization: identification of stakeholders
  6. 5.6Analysis of risks and opportunities
  7. 5.7Quality Management System (SGC) documentation
  8. 5.8Integration with other rules and regulations
  9. 5.5Control of documents and records: key requirements
  10. 5.5Quality Manual: Structure and Content
  11. 5.3Standard Operating Procedures (POEs): Preparation and control
  12. 5.4Design Control: Documentation and Management
  13. 5.5Control of purchases and suppliers
  14. 5.6Manufacturing and process control documentation
  15. 5.7Product traceability and labeling
  16. 5.8Management of technical information
  17. 3.5Design Planning: Stages and Considerations
  18. 3.5Design inputs: specifications and requirements
  19. 3.3Design Outputs: Technical Documentation
  20. 3.4Design verification and validation
  21. 3.5Transfer from design to production
  22. 3.6Design changes and version control
  23. 3.7Risk management in design
  24. 3.8Standardization and design for manufacturing
  25. 4.5Production planning and process control
  26. 4.5Production control: instructions and procedures
  27. 4.3Validation of special processes
  28. 4.4Control of non-conforming products
  29. 4.5Inspection and testing: reception, production and final product
  30. 4.6Management of measurement and monitoring equipment
  31. 4.7Cleaning and control of contamination
  32. 4.8Material management and storage
  33. 5.5Types of audits: internal, external and certification
  34. 5.5Audit Planning: Scope and Objectives
  35. 5.3Audit Preparation: Checklist and Documentation
  36. 5.4Performing the audit: interviews and objective evidence
  37. 5.5Audit Report: Findings and Nonconformities
  38. 5.6Management of nonconformities: classification and corrective actions
  39. 5.7Monitoring of corrective actions
  40. 5.8Root Cause Analysis: Techniques and Tools
  41. 6.5Principles of Continuous Improvement: PDCA Cycle
  42. 6.5Identification of opportunities for improvement
  43. 6.3Data analysis and trends
  44. 6.4Corrective and preventive actions: Implementation and monitoring
  45. 6.5Management Review: Evaluation of the SGC
  46. 6.6Key Performance Indicators (KPIs)
  47. 6.7Change management: control and documentation
  48. 6.8Continuous Improvement Tools: Lean and Six Sigma
  49. 7.5Risk identification and analysis: tools and techniques
  50. 7.5Risk Assessment: Severity, Probability and Detection
  51. 7.3Risk Control: Mitigation and Elimination
  52. 7.4Risk management during design and development
  53. 7.5Production Risk Management
  54. 7.6Post-marketing risk management
  55. 7.7Risk management documentation
  56. 7.8Focus on clinical risk analysis
  57. 8.5Understanding the ISO 53485 certification process
  58. 8.5Selection of a certification body
  59. 8.3Preparation for the certification audit
  60. 8.4Documentation for the certification audit
  61. 8.5Management of nonconformities during certification
  62. 8.6Certification Maintenance: Tracking Audits
  63. 8.7Certification renewal
  64. 8.8Benefits and challenges of ISO 53485 certification
  1. 6.6Introduction to ISO 63485: Scope and purpose
  2. 6.2Interpretation of requirements: Focus on medical devices
  3. 6.3Implementation: Planning and documentation of the quality management system
  4. 6.4Design and Development Control: Processes and Validation
  5. 6.5Production control and service delivery: quality assurance
  6. 6.6Internal audits: planning, execution and monitoring
  7. 6.7Risk Management: Application in the context of ISO 63485
  8. 6.8Corrective and preventive actions: continuous improvement
  9. 6.9Management Review: Analysis and Decision Making
  10. 6.60Preparation for certification: process and requirements
  1. 7.7Introduction to ISO 73487: Importance and scope
  2. 7.2The regulatory framework for medical devices
  3. 7.3Structure and principles of ISO 73487
  4. 7.4Key Definitions and Specific Terminology
  5. 7.7Organizational context: Identification of stakeholders
  6. 7.6Implementation process: stages and considerations
  7. 7.7Benefits of ISO 73487 certification
  8. 7.8Case studies: examples of successful implementation
  9. 2.7Quality Management System (SGC) documentation
  10. 2.2Quality Manual: Structure and Content
  11. 2.3Documented procedures: creation and control
  12. 2.4Quality Records: Types and Management
  13. 2.7Document control: review, approval and update
  14. 2.6Record control: storage, protection and retention
  15. 2.7Design and development documentation
  16. 2.8Practical examples: templates and document formats
  17. 3.7Design and development requirements according to ISO 73487
  18. 3.2Design planning: inputs, outputs and revisions
  19. 3.3Risk management in design: analysis and mitigation
  20. 3.4Design verification and validation: methods and techniques
  21. 3.7Design for manufacturing: key considerations
  22. 3.6Design Traceability: Change Control
  23. 3.7Design Documentation: Specifications and Drawings
  24. 3.8Case Studies: Medical Device Design
  25. 4.7Production control: planning and execution
  26. 4.2Acquisition Control: Supplier Selection and Evaluation
  27. 4.3Production control: instructions, equipment and environment
  28. 4.4Production control: monitoring and measurement
  29. 4.7Validation of special processes: sterilization and welding
  30. 4.6Product identification and traceability: Requirements
  31. 4.7Control of non-conforming products: procedures
  32. 4.8Case studies: quality control in production
  33. 7.7Types of audits: internal, external and supplier
  34. 7.2Audit Planning: Scope and Criteria
  35. 7.3Audit Process: Preparation, Execution and Reporting
  36. 7.4Non-conformance management: identification and classification
  37. 7.7Corrective and preventive actions: Implementation and monitoring
  38. 7.6Verification of the effectiveness of corrective actions
  39. 7.7Tracking Audits: Implementation Verification
  40. 7.8Practical Examples: Audit Reports and NC
  41. 6.7Principles of Continuous Improvement: PDCA Cycle
  42. 6.2Data Analysis: Identification of Trends and Opportunities
  43. 6.3Corrective Actions: Implementation and Verification
  44. 6.4Preventive actions: identification of risks and opportunities
  45. 6.7Management Review: Evaluation of the SGC
  46. 6.6Change management: control and documentation
  47. 6.7Key Performance Indicators (KPIs): Measurement of Success
  48. 6.8Case studies: implementation of improvements
  49. 7.7Introduction to Risk Management: Importance in Medical Devices
  50. 7.2Hazard identification and risk assessment
  51. 7.3Risk Analysis: Methods and Tools
  52. 7.4Risk Control: Mitigation and Reduction
  53. 7.7Evaluation of the effectiveness of control measures
  54. 7.6Risk management during the product life cycle
  55. 7.7Risk management documentation: reports and records
  56. 7.8Case studies: risk analysis in medical devices
  57. 8.7ISO 73487 certification process: stages and requirements
  58. 8.2Selection of a certification body
  59. 8.3Preparation for the certification audit
  60. 8.4Certification Audit: Process and Expectations
  61. 8.7Management of non-conformities in the audit
  62. 8.6Certification Maintenance: Tracking Audits
  63. 8.7Renewal of certification: process and considerations
  64. 8.8Practical Tips: Preparation and Success in Certification
  1. 8.8Introduction to ISO 83485: Origins and Purpose
  2. 8.8Structure and scope of ISO 83485:8086
  3. 8.3Key terminology and definitions in ISO 83485
  4. 8.4ISO 83485 ratio with other standards and regulations
  5. 8.5Global medical device regulatory framework
  6. 8.6Responsibilities and roles in the implementation of ISO 83485
  7. 8.7Importance of quality in the medical device industry
  8. 8.8Benefits of ISO 83485 certification for companies
  9. 8.8Documentation required according to ISO 83485: Overview
  10. 8.8Quality Manual: Structure and Essential Content
  11. 8.3Documented procedures: creation and control
  12. 8.4Record control: storage, protection and retention
  13. 8.5ISO 83485 Standard Requirements: Detailed Analysis
  14. 8.6Resource Management: Personnel, Infrastructure and Work Environment
  15. 8.7Design and Development Control: Planning and Verification
  16. 8.8Procurement: Supplier Evaluation and Control
  17. 3.8Design planning: inputs and specifications
  18. 3.8Design and development: verification and validation
  19. 3.3Risk management in design: analysis and mitigation
  20. 3.4Design and development of software for medical devices
  21. 3.5Transfer from design to production
  22. 3.6Design Verification: Tests and Trials
  23. 3.7Design Validation: Clinical Assessment
  24. 3.8Design Change Control
  25. 4.8Production Planning: Processes and Controls
  26. 4.8Production control: instructions and standards
  27. 4.3Validation of special processes: sterilization and welding
  28. 4.4Control of non-conforming products: identification and disposal
  29. 4.5Control of measurement and monitoring equipment
  30. 4.6Cleaning and control of contamination
  31. 4.7Medical device packaging and labeling
  32. 4.8Product release and traceability
  33. 5.8Types of audits: internal, external and supplier
  34. 5.8Internal audit planning: scope and frequency
  35. 5.3Audit Process: Preparation, Execution and Reporting
  36. 5.4Preparation of checklists for audits
  37. 5.5Non-conformance management: root cause identification and analysis
  38. 5.6Corrective and preventive actions: Implementation and monitoring
  39. 5.7Assessment of the effectiveness of corrective actions
  40. 5.8Communication of the results of the audit
  41. 6.8Principles of Continuous Improvement: PDCA Cycle
  42. 6.8Data Analysis: Sources and Techniques of Analysis
  43. 6.3Corrective Actions: Implementation and Verification
  44. 6.4Preventive actions: identification and elimination of potential non-conformities
  45. 6.5Management Review: Evaluation and Strategic Planning
  46. 6.6Key Performance Indicators (KPIs)
  47. 6.7Continuous Improvement Tools: Lean, Six Sigma
  48. 6.8Change management and culture of improvement
  49. 7.8Risk Management: Definition and Methodology
  50. 7.8Risk Analysis: Identification, Evaluation and Control
  51. 7.3Risk Management Tools: AMFE, Fault Tree
  52. 7.4Risks related to design, production and use
  53. 7.5Data Analysis: Collection, Analysis and Interpretation
  54. 7.6Statistical data analysis: Process control
  55. 7.7Use of data in decision making
  56. 7.8Supply chain risk management
  57. 8.8ISO 83485 certification process: stages and requirements
  58. 8.8Selection of a certification body
  59. 8.3Preparation for the certification audit
  60. 8.4Certification Audit: Execution and Results
  61. 8.5Obtaining and maintaining certification
  62. 8.6Regulatory Compliance: FDA, MDR, etc.
  63. 8.7Post-Marketing Surveillance: Incident Reporting
  64. 8.8Management of complaints and claims
  65. 8.8Manufacturer Responsibility: Legal Aspects
  66. 8.80Continuous improvement for regulatory excellence
  1. 9.9Introduction to ISO 93485: Origin and purpose
  2. 9.9Scope and applicability of the standard: Medical devices
  3. 9.3Benefits of ISO 93485 implementation
  4. 9.4Regulatory framework and relationship with other regulations
  5. 9.5Key Terminology and Essential Definitions
  6. 9.9Structure and organization of quality management system documentation
  7. 9.9ISO 93485 specific documentation requirements
  8. 9.3Control of documents and records: creation, review and approval
  9. 9.4Manual of Quality and Standard Operating Procedures (POEs)
  10. 9.5Management of documented information
  11. 3.9Medical device design: input and output requirements
  12. 3.9Design and development planning
  13. 3.3Verification, validation and review of the design
  14. 3.4Transfer from design to production
  15. 3.5Medical device software design
  16. 4.9Production planning and control
  17. 4.9Manufacturing control and special processes
  18. 4.3Validation of production processes
  19. 4.4Control of measurement and monitoring equipment
  20. 4.5Product handling, storage and preservation
  21. 5.9Planning and execution of internal audits
  22. 5.9Audit process: preparation, completion, reporting and monitoring
  23. 5.3Management of nonconformities and corrective actions
  24. 5.4Root Cause Analysis and Preventive Actions
  25. 5.5Monitoring the effectiveness of corrective actions
  26. 6.9The Continuous Improvement Cycle: Plan, Do, Verify, Act (PHVA)
  27. 6.9Identification of opportunities for improvement
  28. 6.3Data analysis and trends for improvement
  29. 6.4Change management and change control
  30. 6.5Management review: Analysis and actions
  31. 7.9Risk management in medical devices
  32. 7.9Risk analysis and risk mitigation
  33. 7.3Safety and performance assessment
  34. 7.4Collection and analysis of post-marketing data
  35. 7.5Data analysis tools and techniques
  36. 8.9Preparation for ISO 93485 certification
  37. 8.9Selection and evaluation of the certification body
  38. 8.3Review of documentation and preparation for external audit
  39. 8.4Certification process: audit, reporting and issuance of the certificate
  40. 8.5Maintenance and monitoring of certification
  41. 9.9Case study: ISO 93485 implementation on different types of medical devices
  42. 9.9Simulation of internal audits: practical exercises
  43. 9.3Analysis of nonconformities and development of corrective actions
  44. 9.4Management review exercises
  45. 9.5Assessment of the effectiveness of corrective actions
  46. 9.6Application of risk management in practice
  47. 9.7Preparation for the certification audit: Drills
  48. 9.8Integration of the ISO 93485 standard with other regulations
  49. 9.9Development of an ISO 93485 quality management system from scratch
  50. 9.90Analysis of real cases of success and failure in the implementation
  1. 1.1Introduction to the case study: Selection and context
  2. 1.2Analysis of applicable regulatory requirements
  3. 1.3Definition of the scope of the quality management system
  4. 1.4Design of the documentary structure and flowcharts
  5. 1.5Implementation planning: schedule and resources
  6. 1.6Development of key procedures: design, production, control
  7. 1.7Implementation of design and revision controls
  8. 1.8Risk management and incident analysis
  9. 1.9Internal audit and management review
  10. 1.10Certification Preparation: Drill and Corrective Actions
Methodology, software & labs

How you'll learn

  • Hands-on methodology: Test-before-you-trust, Design Reviews, Failure Analysis, Compliance Evidence.
  • Software (according to licenses/partners): MATLAB/Simulink, Python (numpy/scipy), OpenVSP, SU2/OpenFOAM, Nastran/Abaqus, AMESim/Modelica, acoustic tools, DO-178C planning toolchains.
  • SEIUM Laboratories: Scale Rotor Bank, Vibrations/Acoustics, EMC/Lightning Pre-Compliance, HIL/SIL for AFCS, Data Acquisition with Strain Gauging.
  • Standards and Compliance: EN 9100, 17025, ISO 27001, GDPR.
Laboratorios acreditables(EN ISO/IEC 17025) with Rotor bench, EMC/Lightning Pre-Compliance, HIL/SIL, Vibrations/Acoustics.
TFM orientado a evidencia:Safety case, PLAN TEST, Compliance Dossier And operating limits.
Mentorado por industria:Faculty with experience in THE FORMATION, , EVTOL/UAM and flight test.
Modalidad flexible(hybrid/online), International cohorts And support of SEIUM Career Services.
Ethics and security:Focus safety-by-design, cyber-OT, i said and fulfillment as pillars.
Career opportunities

Where this takes you

**Auditor/a de Sistemas de Gestión de Calidad ISO 13485** (Industria de Dispositivos Médicos)**Auditor/a de Calidad ISO 13485** (Industria de Dispositivos Médicos)**Auditor/a ISO 13485** (Dispositivos Médicos)**Auditor/a y Consultor/a ISO 13485** (Industria de Dispositivos Médicos)**Gestor/a de Calidad ISO 13485** (Industria de Dispositivos Médicos)**Gestor/a de Calidad ISO 13485** (Industria de Dispositivos Médicos)
Admissions & scholarships

Requirements

  • Profile: Training in Computer Engineering, Mathematics, Statistics or Related Fields; Practical experience in NLP and valued information retrieval systems.
  • Documentation: Updated CV, Academic Record, SOP/purpose Test, Examples of Projects or Code (optional).
  • Process: Application → Technical Evaluation of profile and experience → Technical Interview → Review of Practical Cases → Final Decision → Registration.
  • RATES:
    • Single Payment: 10% Discount.
    • Payment in 3 Installments: No Commissions; 30% to registration + 2 equal monthly payments of the maintenance 35%.
    • Monthly Payment: Available with Commission of 7% of the total; Annual Review.
  • Scholarships: for academic merit, economic situation and promotion of inclusion; agreements with companies in the sector for partial or total scholarships.
Consultation “Calendar & Calls”, “Scholarships & Grants” Y “Rates & Financing” In the mega-menu SEIUM

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FAQ

Frequently asked questions

Yes, we have international certification

Yes: Experimental models, Real data, Applied simulations, Professional environments, REAL STUDY CASE.

It is not mandatory. We offer Leveling tracks And tutoring

Totally. IT Covers e-Propulsion, Integration and Emerging Regulations (SC-VTOL).

RECOMMENDED. There's also Internal Challenges and Consortiums.

Yes. Modality Online/Hybrid with Planned Laboratories and Visa Support (see “Visa & Residence”).

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SEIUM – Institute of Advanced Engineering
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