- Introduction to the regulatory requirements for CE certification of your medical device.
- Design for six sigma (market CTQs, internal CTQs, MSA), verification and validation based on statistics & reliability.
- Project management in medical device development.
Course information
- 3 days
- 8 and 23 April + 14 May 2024
Investment
The investment is € 2.550,- (excl. VAT) per participant. Included are three training days, course material, tools and templates, lunches and beverages.
Curious?
Talk to our academy advisorAbout the course Fundamentals in Medical Device Development.
The development process starts with an idea and ends with a medical device that is safe, suitable for its intended purpose and is, most of all, CE certified (by a notified body). This newly developed course provides insights into the different roles involved within the product development process.
The course Fundamentals in Medical Device Development will show how the expertises Regulatory, Design for Six Sigma and Project Management cooperate as a team to successfully complete the design of the medical device. It creates a better understanding and internal synergy for an improved flow and market introduction.
With this course you’ll learn:
- To understand the project management framework in addition to design controls & risk management
- Get enthusiastic involvement of engineers, architects, and managers in order to comply with the medical device regulations and to execute projects effectively and completely
- To define and understand customer needs coupled with critical device requirements
Teaching professionals.
Wim Schouten
Sr. Project Manager
Wim is a result- and people driven experienced program manager, managing innovative and ambitious multidisciplinary technical product development projects. Over 30 years of experience with successful project management, change management of people and organization, over 25 years as manager. Besides this he is a certified coach. He translates strategy and policy into concrete targets, projects and processes and leads the execution.
Theo de Goede
Sr. Project Manager & Master Black Belt
Theo is an experienced and passionate Master Black Belt in Six Sigma, with a specialization in managing product development and process improvement projects. His skills can be applied in all technical and business situations where management and improvement of (product design) processes is a common factor. Final goal; a design or production process that meets customer needs.
Lisette van Steinvoren - Stamsnijder
Competence Lead MedTech & Sr. Project Manager Medical
Lisette is a dedicated project manager with several years of experience in innovative product development within both multinationals and SMEs. She is passionate about creating relevant products, especially when they are health and environmental related. Lisette has a background in Engineering Physics & Innovation Management. She is Black Belt and IPMA C certified.
Relevant courses.
HI-MT4 CE Certification of your IVD Medical Device
MedTechGet an overview of the regulatory requirements and learn how to implement these in your development process.
Lisanne Karbaat
Project Manager Medical Devices
- 4 days
HI-PM1 Project Management Masterclass
Project ManagementThis course will teach you the essence and application of project management and Agile leadership.
Wim Schouten
Sr. Project Manager
- 4 days
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