Course information

  • 3 days
  • 14 April, 7, and 27 May 2025

Investment

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

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About the course Fundamentals in Medical Device Development.

This proven effective course provides the practical knowledge to understand and directly apply the coherence between the requirements of the MDR and the different standards in your own product development process.

The course Fundamentals in Medical Device Development will show how the expertises Regulatory, Product Design & Development, and Project Management cooperate as a team to successfully complete the design of your medical device. Navigating through standards can often be a challenging task. That is why our training sessions blend theoretical insights with practical, hands-on workshops. It results in enthusiastic involvement of engineers, architects, and managers in order to comply with the medical device regulations and to execute projects effectively.

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With this course you’ll learn:

  • How to pragmatically comply to the requirements of the MDR (2017/745) and the applicable standards (e.g. ISO 14971, ISO 13485, IEC 62366).
  • Defining and designing a product that not only ensures safety but also meets your users' needs effectively.
  • To understand the project management framework in addition to design controls & risk management.

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.

Outcome

During the course Fundamentals in Medical Device Development, you will learn how to execute and facilitate a medical device development project by using the applicable regulatory framework for your medical device risk class. This can be achieved by incorporating these regulatory frameworks into your designs and risk assessments, and realizing EU market introduction within time and budget.

Fundamentals in Medical Device Development

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What you’ll learn.

Program
Day 1:
  • Regulatory, standards, QMS. 
  • Introduction to the regulatory requirements for CE certification of your medical device.

Day 2:

  • Design for Six Sigma (market CTQs, internal CTQs, MSA).
  • Verification and Validation based on statistics & Reliability.

Day 3:

  • Project management in medical device development: project planning, work-breakdown structure, project risk management.
  • Stakeholder management and engagement of the project team. 

Relevant courses.

HI-MT3 In Vitro Diagnostic Medical Devices - Getting started with CE Certification

MedTech

Get an overview of the regulatory requirements and learn how to implement these in your development process.

Lisanne Karbaat
Lisanne Karbaat
Project Manager Medical Devices
  • 1 day
Learn more about this course

HI-PM1 Project Management Masterclass

Project Management

This course will teach you the essence and application of project management and Agile leadership. 

Wim Schouten
Wim Schouten
Sr. Project Manager
  • 4 days
Learn more about this course
Explore more

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.

Certificate

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

Locations 
Eindhoven – High Tech Campus 29 
Enschede –  Hengelosestraat 500 (Building The Gallery) 
Zeist - Utrechtseweg 48


Dates 2025

Session I: 14 April, 7 and 27 May

Session II: 29 October, 24 November, and 16 December



Group size 

A maximum of 10 participants 

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