KURSUS
Project Management for Product Development of Medical Devices
Learn how to manage medical device development projects in a highly regulated environment. This course combines practical project management tools with design control requirements to help you ensure both development maturity and project progress.
Kursusdetaljer
Hørsholm
2. november 2026
Varighed: 3 dage
19.350,00 - 29.750,00 kr.
Priser er ekskl. moms
Engelsk
This course focuses on how to manage the development process for new medical devices and maintain them within an organization where design control requirements apply.
The course combines key project management tools with the design control process, giving participants a unique opportunity to learn how to manage development projects in the medical device industry while gaining detailed knowledge of the design control documentation required by regulatory authorities.
A particular challenge in medical device development is managing multiple stakeholders and project team members in a highly regulated environment. The course introduces a unique tool designed to ensure sufficient development maturity while maintaining the necessary progress throughout the project lifecycle.
Dissemination of contact information
Medicoindustrien
The course is offered in collaboration with MedicoIindustrien, and the contact details of enrolled participants are therefore shared
The contact information is used exclusively in connection with your registration and for the course itself, but will not be used for marketing purposes.
Who should attend:
The course is relevant for:
- R&D engineers wanting to become project managers
- Consultants working with medical device projects and design control
- Project managers from other industries that have moved to the medical device industry
- Medical device industry project managers
- Managers working directly or indirectly with projects and product development
Recommended minimum pre-requisites for this course are any or all of the following:
- Experience with product development in a regulated industry
- Experience from working in project organization, or with ISO 13485/21 CFR 820
The course is offered in collaboration with Medicoindustrien, and participants’ contact details are therefore shared with Medicoindustrien.
Your outcome
After completing the course, you will have improved skills in organizing and managing medical device development projects. You will gain a better understanding of how to handle project risks, manage stakeholders and project teams, and ensure project progress in compliance with design control requirements.
You will also strengthen your understanding of how and why design control requirements should be implemented and how to avoid common pitfalls in medical device product development
Advantages for your company:
Organizations will benefit from improved efficiency and structure in medical device development projects. The course provides pragmatic methods, tools, and techniques that support compliant development processes, improved project progress, and higher development maturity, leading to more robust documentation and reduced regulatory risk.
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Katharina Laungaard
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