Course curriculum

    1. Welcome to the DQS Design and Development Course

    2. What we will cover (Part 1)

    3. What we will cover (Part 2)

    4. Design and Development course objectives

    1. Learning objectives

    2. Design and Development Introduction (Part 1)

    3. Design and Development Introduction (Part 2)

    4. Design and Development Introduction (Part 3)

    5. Design and Development Introduction (Part 4)

    6. Design and Development Introduction (Part 5)

    7. Design and Development Introduction (Part 6)

    8. Design and Development Introduction (Part 7)

    9. Design and Development Introduction (Part 8)

    10. Design and Development Introduction (Part 9)

    11. Design and Development Introduction (Part 10)

    12. Design and Development Introduction (Part 11)

    13. Design and Development Introduction (Part 12)

    14. Design and Development Introduction (Part 13)

    15. Design and Development Introduction (Part 14)

    16. Quiz – Chapter 1: Introduction to Design and Development

    1. Learning Objectives

    2. Design Planning (Part 1)

    3. Design Planning (Part 2)

    4. Design Planning (Part 3)

    5. Design Planning (Part 4)

    6. Design Planning (Part 5)

    7. Design Planning (Part 6)

    8. Design Planning (Part 7)

    9. Design Planning (Part 8)

    10. Design Planning (Part 9)

    11. Design Planning (Part 10)

    12. Quiz – Chapter 2: Design Planning

    1. Learning Objectives

    2. Design and Development Example (Part 1)

    3. Design and Development Example (Part 2)

    4. Design and Development Example (Part 3)

    5. Design and Development Example (Part 4)

    6. Design and Development Example (Part 5)

    7. Design and Development Example (Part 6)

    8. Design and Development Example (Part 7)

    9. Design and Development Example (Part 8)

    10. Quiz – Chapter 3: Design and Development Example

    1. Learning Objectives

    2. User and Stakeholder Needs (UN/SN) – Definitions (Part 1)

    3. User and Stakeholder Needs (UN/SN) – Definitions (Part 2)

    4. User and Stakeholder Needs (UN/SN) (Part 1)

    5. User and Stakeholder Needs (UN/SN) (Part 2)

    6. User and Stakeholder Needs (UN/SN) (Part 3)

    7. User and Stakeholder Needs (UN/SN) (Part 4)

    8. User and Stakeholder Needs (UN/SN) (Part 5)

    9. User and Stakeholder Needs (UN/SN) (Part 6)

    10. User and Stakeholder Needs (UN/SN) (Part 7)

    11. User and Stakeholder Needs (UN/SN) (Part 8)

    12. User and Stakeholder Needs (UN/SN) (Part 9)

    13. User and Stakeholder Needs (UN/SN) (Part 10)

    14. User and Stakeholder Needs (UN/SN) (Part 11)

    15. User and Stakeholder Needs (UN/SN) (Part 12)

    16. User and Stakeholder Needs (UN/SN) (Part 13)

    17. User and Stakeholder Needs (UN/SN) (Part 14)

    18. User and Stakeholder Needs (UN/SN) (Part 15)

    19. User and Stakeholder Needs (UN/SN) (Part 16)

    20. User and Stakeholder Needs (UN/SN) (Part 17)

    21. User and Stakeholder Needs (UN/SN) (Part 18)

    22. User and Stakeholder Needs (UN/SN) (Part 19)

    23. Practice Device

    24. Quiz - Chapter 4: User and Stakeholder Needs (UN/SN)

    25. Practice device - Recap

    1. Learning objectives

    2. Design Input (DI) – Definitions (Part 1)

    3. Design Inputs (DI) (Part 1)

    4. Design Inputs (DI) (Part 2)

    5. Design Inputs (DI) (Part 3)

    6. Design Inputs (DI) (Part 4)

    7. Design Inputs (DI) (Part 5)

    8. Design Inputs (DI) (Part 6)

    9. Design Inputs (DI) (Part 7)

    10. Design Inputs (DI) (Part 8)

    11. Design Inputs (DI) (Part 9)

    12. Design Inputs (DI) (Part 10)

    13. Design Inputs (DI) (Part 11)

    14. Design Inputs (DI) (Part 12)

    15. Design Inputs (DI) (Part 13)

    16. Design Inputs (DI) (Part 14)

    17. Practice Device

    18. Quiz - Chapter 5: Design Inputs (DI)

    19. Practice device - Recap

About this course

  • $2,500.00
  • 244 lessons
  • 1.5 hours of video content
  • 14 lessons
  • Downloadable content

Design and Development

Our Design and Development course was built by practitioners, for practitioners. We have engaged with clients and regulators around the globe implementing this approach with success. We believe our approach is unlike other Design and Development course. Our course is asynchronous with a generous 30 day time limit.

  • Understand the regulatory requirements that mandate Design and Development processes and explain when these processes apply throughout the development lifecycle.

  • Create Design and Development Plans that establish project scope, team responsibilities, interfaces, schedules, and risk management strategies.

  • Gather and document User Needs and Stakeholder Needs using appropriate methods, then translate these into measurable, verifiable Design Inputs that serve as the foundation for device design.

  • Plan and conduct effective Design Reviews at appropriate development stages, integrate Risk Management principles throughout the design process, and apply Failure Mode and Effects Analysis (FMEA) methodologies.

  • Create comprehensive Design Outputs that address all Design Input requirements, identify Essential Design Outputs based on safety and proper functioning criteria, and establish complete traceability documentation.

  • Plan and conduct Design Verification to confirm outputs meet inputs, and Design Validation to ensure the device meets User Needs using production-equivalent devices in actual or simulated use conditions.

  • Successfully transfer designs from development to production using systematic procedures, and implement effective change control processes throughout the device lifecycle.

  • Create and maintain comprehensive Medical Device Files (MDF) that demonstrate compliance, apply technical writing principles for clear documentation, and prepare for evolving regulatory requirements.