This two day course is focused on how to develop new medical devices and maintaining them in an organisation where design control requirements apply. The course covers both European and US requirements.
The course gives a broad introduction to the development process for new medical devices with focus on the different development documents required by the authorities.
The course addresses the interactions between the key documents starting with the Development Planning and ending with the Process validation as part of the Design Transfer Process. Because the Risk Management Process is the process that “controls” the safety of the device, the course will give the participants a clear picture of the connections between the risk depending on documents, from the Risk Management Plan to the Clinical Evaluation Report.
The course addresses what level of documentation is required according to both EU MDR and FDA 21CFR and provides tools on how to work successfully and efficiently with design control. Since standards play a significant role in design control and development of medical devices, the course will reference the most commonly used standards that apply to medical devices. This includes ISO 14971 on risk management, IEC 62366 on usability engineering, IEC 60601 on electrical safety and IEC 62304 on medical device software. You will also learn about the most common pitfalls in medical device product development.
The learning goals of the course are to:
- Provide pragmatic methods, tools and techniques which will boost the ability to be efficient in the development of medical devices and the related documentation
- Improve understanding of how and why design control requirements should be implemented.
- Increase knowledge on the most common pitfalls in medical device product development and how to avoid them
The course comprises lectures and interactive workshops. The trainer will follow up on learning objectives throughout the course. This means that you will have to answer questions on the topics covered to ensure that the objectives are met.
Who should attend
The course is targeted towards professionals who are involved in the following areas:
- Development of medical devices
- Quality Assurance
- Project Managers within the medical device area
There are no pre-requisites, but it is helpful to have experience from product development in medical device industry or any other regulated industry or experience from the medical device industry in general.
Søren Lyngsø-Petersen, CEO, Pharma4ever QA ApS
"My general understanding of the design control concepts and process was hugely improved"
"Great exposure to the broad field of QA/design control"
"Liked the general overview of what is expected from a sound Design Control Process"
"The course material was explained in a very simple and understandable manner"
"It covered the newest information about design control"
Participants, Fall 2021