Course information

  • 3 days
  • 8 and 23 April + 14 May 2024


The investment is € 2.550,- (excl. VAT) per participant. Included are three training days, course material, tools and templates, lunches and beverages.

About 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.

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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

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

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

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.

Course: Fundamentals in Medical Device Development.


During the course Fundamentals in Medical Device Development, you will learn how to execute and facilitate a medical device development project by using design and development plans, design reviews, risk analysis and FMEA as an integral part of your product development process.

New products, processes and systems need to be developed faster and with increasing quality, safety and reliability levels. Specifically in the medical device industry, regulations and quality management systems are the key elements for success. Design flaws, rework, warranty claims or even brand image loss need to be prevented.

Fundamentals in Medical Device Development

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What you’ll learn.


What you'll learn on day 1, day 2 and day 3 of the course

  • 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.

Practical information.

For whom

The Fundamentals in Medical Device Development course is designed for managers and engineers who are tasked with managing and executing medical device projects, project teams and regulatory/engineering activities.


Participants who have followed the full course receive a certificate of participation.

After the training, Holland Innovative optionally offers on-the-job coaching to further improve and implement the medical device development process and practices in your company.

Location & Dates

Eindhoven – High Tech Campus 29 
Enschede –  Hengelosestraat 500 (Building The Gallery) 
Dates 2024

Session I

8 and 23 April + 14 May

Session II

5 and 16 September + 14 October

Group size 

A maximum of 10 participants 

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