Design Control in the Field of Medical Devices
Developing Medical Devices Safely: Regulatory Requirements according to 21 CFR 820, ISO 13485:2016
The success of a medical device is shaped long before it reaches the market—its foundations are set during the product development phase. Ensuring safety, usability, and performance from the very beginning is essential.
This training provides a comprehensive and practical introduction to the key elements of medical device development in alignment with FDA 21 CFR 820 (QMSR), ISO 13485:2016, and the Medical Device Single Audit Program (MDSAP).
Throughout the course, you will learn the core terminology, understand regulatory expectations, and explore real-world methods and examples that demonstrate how to apply design control principles effectively.
By the end of the training course, you will be able to:
- Integrate regulatory requirements into a compliant and efficient development process
- Understand the purpose and structure of Design Control
- Distinguish clearly between design verification and design validation
- Document development activities and results appropriately
- Consider the full product lifecycle—from concept through end-of-life management—in every development decision
This course equips you with the knowledge and confidence to implement robust design control processes within your organization, ensuring the development of safe, effective, and compliant medical devices.
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
Persons involved in the development of medical devices, such as:
- QM specialists
- Developers
- Project managers
- Regulatory affairs
- Managers with development responsibility
- Consultants and auditors
- Service providers
Day 1: Basics of Design Control
- Overview of the current state of legislation (21 CFR 820) and standardization (ISO 13485:2016)
- Design and development planning
- From User Needs to Design Input
- Design Verification, Design Output, and Validation
- Design Transfer
- Design Reviews
Day 2: Workshop
- Implementation-oriented workshop on the creation of the essential design control elements using a real example from the field of non-active medical devices
- User Needs and their Implementation in Design Input
- Design and Development Plan
- Design, Verification and Validation
- Statistical sampling plans
- Design Change Management
- DHF (Design History File) and Design Development File
- Dealing with external and older documentation
Successful medical devices are built on robust development processes. Long before a product reaches the market, critical decisions made during design and development determine its safety, efficacy, usability, regulatory compliance, and commercial success. Design Control provides the structured framework required to ensure that medical device development consistently meets these objectives.
This intensive two-day training provides a practical and comprehensive understanding of Design Control requirements in accordance with ISO 13485:2016, the revised FDA 21 CFR Part 820 Quality Management System Regulation (QMSR), and expectations relevant to MDSAP environments. Participants gain a clear understanding of the regulatory foundation of Design Control and how these requirements should be applied throughout the medical device lifecycle.
The course guides participants through every major Design Control element, including design and development planning, user needs, design inputs and outputs, design verification, design validation, design transfer, design reviews, risk-based sampling strategies, design change management, and development documentation. Special attention is given to the distinction between verification and validation and to maintaining traceability throughout the development process.
Participants will also learn how Design Control interacts with other key quality system processes such as risk management according to ISO 14971, technical documentation, supplier involvement, regulatory submissions, and post-market activities. Real-world examples, practical templates, and implementation guidance are used to demonstrate how compliant Design Control systems can be established and maintained.
A practical workshop allows participants to apply Design Control concepts using an example medical device development project. Through hands-on exercises, attendees will develop key Design Control elements, understand documentation expectations, and gain practical tools that can be implemented immediately within their organizations.
By the end of this training, participants will be able to:
- Explain the purpose and regulatory basis of Design Control
- Interpret Design Control requirements from ISO 13485:2016 and FDA QMSR
- Create effective design and development plans
- Define and document user needs and design inputs
- Generate compliant design outputs and maintain traceability
- Apply risk management principles during design and development activities
- Plan and execute design verification and validation activities
- Select appropriate risk-based sampling approaches
- Conduct and document design reviews effectively
- Implement design transfer activities into manufacturing
- Manage design changes using risk-based approaches
- Structure and maintain Design Development Files and Technical Documentation
- Integrate supplier and third-party design documentation into Design Control systems
- Evaluate and remediate gaps in legacy development documentation
Upon completion of this course, you will be able to:
- Understand Design Control requirements under ISO 13485:2016 and FDA QMSR (21 CFR Part 820)
- Build compliant and efficient medical device development processes
- Translate user needs into measurable design inputs
- Establish traceability from user needs through verification and validation
- Distinguish clearly between design verification and design validation
- Integrate risk management activities into product development
- Develop and maintain effective Design and Development Plans
- Conduct meaningful design reviews at critical project milestones
- Implement risk-based statistical sampling plans for verification and validation activities
- Manage design changes throughout the product lifecycle
- Prepare and maintain Design Development Files, Design History Files, Medical Device Files, and technical documentation
- Address gaps in legacy product documentation
- Manage supplier-generated and externally developed design documentation
- Apply Design Control principles using practical examples and workshop exercises
This instructor-led Live Online training combines regulatory theory with practical implementation guidance.
Participants will learn through:
- Expert-led presentations
- Interactive discussions
- Real-world examples
- Case studies
- Practical Design Control exercises
- Workshop activities based on a medical device development scenario
- Group problem-solving activities
- Knowledge checks and instructor feedback
The workshop component enables participants to create and evaluate critical Design Control deliverables, including development plans, user needs, design inputs, verification plans, validation plans, and review activities.
Participants who attend at least 90% of the total training duration will receive an official Certificate of Attendance from TÜV SÜD Academy.
Participants will benefit from having:
- A basic understanding of medical device development processes
- Familiarity with Quality Management Systems in the medical device industry
- General awareness of ISO 13485 or medical device regulatory requirements
No advanced Design Control experience is required.
What is Design Control in medical device development?
Design Control is a structured process used to plan, document, verify, validate, review, and control medical device development activities to ensure products are safe, effective, and compliant with regulatory requirements.
Which regulations and standards are covered?
The course covers:
- ISO 13485:2016
- FDA 21 CFR Part 820 (QMSR)
- MDSAP expectations
- ISO 14971 risk management interfaces
- Relevant technical documentation concepts
Is the revised FDA QMSR included?
Yes. The training includes the revised FDA Quality Management System Regulation (QMSR) and explains its relationship to ISO 13485:2016.
What is the difference between design verification and design validation?
Participants learn how verification confirms that design outputs meet design inputs, whereas validation demonstrates that the device fulfills user needs and intended use.
Does the course cover risk management?
Yes. The course explains how risk management activities support Design Control and how ISO 14971 principles are integrated into development, verification, validation, and change management.
Are design reviews covered?
Yes. Participants learn how to plan, conduct, document, and evaluate Design Input Reviews, Design Verification Reviews, and Final Design Reviews.
Does the course address design transfer?
Yes. The training explains how development outputs are transferred into manufacturing and production, including documentation and readiness considerations.
Will statistical sampling plans be discussed?
Yes. The course includes practical guidance on risk-based sampling plans, AQL, LTPD, attribute and variable data, and verification/validation sampling strategies.
Does the course cover Design Change Management?
Yes. Participants learn how to assess, verify, validate, document, and approve design changes throughout the product lifecycle.
What documentation is covered?
The course covers:
- Design Development Files (DDF)
- Design History Files (DHF)
- Medical Device Files (MDF)
- Technical Documentation
- STED concepts
- IMDRF submission structures
Does the course address legacy products?
Yes. The training includes approaches for assessing and remediating older products that may have incomplete design documentation.
Is outsourced development addressed?
Yes. The course discusses integrating supplier-generated documentation, contract development activities, external testing results, and third-party evidence into Design Control processes.
Is there a practical workshop?
Yes. Participants complete a workshop using a realistic medical device development example to apply Design Control concepts and create core Design Control deliverables.
Who should attend?
The course is intended for:
- R&D Engineers
- Design Engineers
- Quality Professionals
- Regulatory Affairs Specialists
- Project Managers
- Quality Managers
- Product Development Leaders
- Consultants and Auditors working in the medical device industry
What certificate will participants receive?
Participants who attend at least 90% of the training will receive a TÜV SÜD Academy Certificate of Attendance.
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