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
- You will learn how to develop medical devices in accordance with ISO 13485:2016 standards.
- You will receive the know-how for the preparation of development documentation in accordance with 21 CFR 820.
- You will learn the essential elements of the Design Control Tool.
- This training deals with internationally valid standards and is also suitable for implementation abroad.
- The contents correspond to the current state of standardization.
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
Certificate of participation from the TÜV SÜD Academy.