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About

Design Controls and Design and Development File Training provides comprehensive knowledge of establishing, implementing, and maintaining compliant design control processes for medical devices and other regulated products. The course covers design planning, design inputs and outputs, design reviews, design verification, design validation, design transfer, design changes, risk management integration, traceability, and documentation requirements in accordance with ISO 13485, FDA 21 CFR 820, and other applicable global regulations.
This Design Controls and Design and Development File Training Course & Certification provides practical guidance on developing and maintaining complete Design and Development Files that demonstrate compliance throughout the product lifecycle. Participants will learn how to generate objective evidence, maintain design traceability, integrate risk management and usability engineering, support regulatory submissions, prepare for audits and inspections, and implement effective design governance aligned with industry best practices.

Who Should Enrol?

  • Design and Development Engineers
  • Quality Assurance Professionals
  • Regulatory Affairs Professionals
  • Research and Development Teams
  • Project Managers and Product Development Leaders
  • Risk Management and Design Assurance Professionals
  • Internal Auditors and Quality System Specialists
  • Anyone involved in medical device design, development, documentation, and regulatory compliance
📢 Every purchase also includes our FREE companion Design Controls and Design and Development File eBook, designed to help you apply principles in real-world inspection readiness settings.

What you will learn

Understand the principles of Design Controls and Design and Development File (DDF) requirements, including regulatory expectations, product lifecycle management, and the relationship between design controls, risk management, and quality management systems.

Learn how to establish and document design planning, design inputs, design outputs, design reviews, design verification, design validation, design transfer, and design changes in compliance with ISO 13485, FDA 21 CFR 820, and applicable global regulations.

Gain practical knowledge of creating and maintaining a complete Design and Development File, including traceability, risk management documentation, usability engineering, software documentation (where applicable), technical records, and objective evidence throughout the product lifecycle.

Understand how to manage design control activities effectively through documentation, change control, configuration management, design history, audit readiness, and continuous improvement to support regulatory compliance and successful product approvals.

Course Syllabus

  1. Why design controls exist
  2. QMSR transition from 21 CFR 820.30
  3. Current versus legacy terminology
  4. When design and development controls apply
  5. The formal start of design and development

  1. Documented design and development procedures
  2. Building the design and development plan
  3. Roles, responsibilities, authorities and interfaces
  4. Resources and competencies
  5. Stage gates and review points
  6. Integrating risk management into planning

  1. Intended purpose and intended use
  2. Users, use environments and conditions of use
  3. Capturing user, patient and stakeholder needs
  4. Translating needs into design inputs
  5. Regulatory, safety and human-factors inputs
  6. Biological, software, cybersecurity and labelling inputs
  7. Making inputs complete, unambiguous and measurable

  1. Developing design outputs
  2. Identifying essential outputs
  3. Defining acceptance criteria
  4. Linking outputs to manufacturing specifications
  5. Establishing bidirectional traceability

  1. Integrating ISO 14971 risk management with design
  2. Human-factors and biological-safety evidence
  3. Software and cybersecurity evidence
  4. Verifying risk-control implementation

  1. Planning and conducting design reviews
  2. Review independence and manufacturing input
  3. Verification versus validation
  4. Verification strategy, methods and evaluation
  5. Validation strategy and production-equivalent units
  6. Usability and clinical evidence; managing failures

  1. Planning design transfer
  2. Verifying outputs before transfer
  3. Transferring manufacturing and inspection requirements
  4. Controlling supplier and contract-manufacturer interfaces
  5. Validating production processes
  6. Controlling design changes and submission impact

  1. Maintaining the design and development file
  2. Using legacy DHF records appropriately
  3. File versus production and device records
  4. Lifecycle traceability
  5. Feeding complaints and PMS back to design
  6. Inspection readiness and common deficiencies

  1. Consolidate the course themes
  2. Reinforce the key guardrails
  3. Building an organisational improvement plan

  1. 📘 Bonus:Design Controls and the Design and Development File eBook (Free with purchase)

Our Certified Customers

novartis
NHS
takeda
roche
baxter

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