HI-MT1 Course Fundamentals in Medical Device Development

Starts with an idea and ends with a medical device that is safe, suitable for its intended purpose, and CE certified.

Fundamentals in Medical Device Development - opening image

With this course you’ll learn:

  • To understand the project management framework and besides 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

Senior Project Manager
Wim has over 30 years of experience with successful project management (more complex than PRINCE2, IPMA) translating strategy and policy to concrete targets, projects and processes and has executed them.
Theo de Goede

Theo de Goede

Senior Project Manager & Master Black Belt
Passionate Master Black in the field of customer-focussed design in the High/Med-Tech field. At Holland Innovative, his knowledge is directed to the Design for Six Sigma and Reliability Engineering area.
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 information

  • Hybrid
  • 3 modules of 1 day


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.

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.

MTs - outcome

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

Yes, save my seat.

We’ll email you within 1 working day with the next steps

What you’ll learn.

Block 1 - day 1/3

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 2022

Location: Enschede
Day 1: May 18 
Day 2: June 16 
Day 3: July 05

Location: Eindhoven
Day 1: September 20 
Day 2: October 06
Day 3: November 01

Group size 

A maximum of 10 participants 

Save your seat

Get started and save your seat.

Take the next step in your personal development.