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 | 3 days

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.

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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 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.

Subjects of the course Fundamentals in Medical Device Development

During the Fundamentals in Medical Device Development course the following subjects will be discussed:

  • Project Management for medical device development
  • Project timeline showing the correlation of all project competences, activities and deliverables
  • Steps in CE certification according to the MDR, using applicable harmonized standards
  • Safety Risk Management, Usability Engineering and Clinical Evaluation
  • Quality Management System based on ISO 13485
  • Design for Six Sigma for medical device development
  • Market CTQs (user needs), internal CTQs, measurement system analysis and reliability tools
  • Verification, validation and appropriate statistical analyses
  • Personal leadership, communication and behaviour

Results of the course Fundamentals in Medical Device Development

During the Fundamentals in Medical Device Development course you will 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

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.

Setup course

The course Fundamentals in Medical Device Development consists of 3 blocks of one day each, from 9 am to 5 pm.

Location, dates, & schedule

This training is offered in our 1.5-meter classrooms, online or hybrid. Moreover, we have both in-company as free enrollment possibilities.

Location: Enschede – The Building, Hengelosestraat 500
Location: Eindhoven – High Tech Campus 29

Data 2021
Location: Eindhoven
Day 1: October 19
Day 2: October 26
Day 3: November 2

Investment course

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


The course will be given by qualified professionals who will assist you in the following areas of knowledge:

• Project Management:
Wim Schouten
Working as a Projectmanager at Holland Innovative, Wim has over 25 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.

• Design for Six Sigma & Reliability::
Theo de Goede
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.

Ton Meek
Seasoned Six Sigma expert supporting improving designs and processes Working as Product & Process Specialist at Holland Innovative.

• Regulatory:
Jolande Koobs
Experienced Project Manager with a demonstrated history of working in the medical device industry. Project management professional and Regulatory specialist skilled in managing the development of (software) products with a strong affinity for Quality assurance and Regulatory affairs.

Lisette van Steinvoren
Projectmanager with several years of experience in –medical device- product development within both multinationals & SME’s, Lisette has a background in Applied Physics & Innovation Management from the University of Utrecht. She is Six Sigma Black Belt and IPMA-C certified. Working as Sr. Project Manager Medical at Holland Innovative

Certificate / diploma

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

Method of teaching

The course is offered as an in-class course, but any other form is open for negotiation. We are able to offer offline, online and hybrid courses. Besides that, there is, either way, plenty of opportunities to do exercises in both workgroups as individuals.

Asking questions, remarks and other interactive moments are encouraged.

Group size

A maximum of 10 participants

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.

This course can also be given specifically within your company.

Training advice?

Would you like to receive more information about this course? Our program managers can tell you more about it! You can reach them from Monday till Friday from 08:30 till 17:00.

T: +31 (0)40 851 4610
E: academy@holland-innovative.nl

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About the Holland Innovative Academy

Holland Innovative helps to develop the competencies of you and your colleagues to strengthen your organization and create growth. Together with renowned centres of expertise such as Eindhoven University of Technology, Twente University, Delft University of Technology and the University of Stuttgart we organize courses, trainings and masterclasses in Project Management, Product & Process Development, Reliability, Data Science and MedTech. We offer both open enrolment and in-company training; tailor-made to fully meet the needs and the strategy of your organization. Coupling these courses with practical experience is important in order to maximise the effectiveness. Where possible, your own cases/data are discussed during our training and/or further explored by coaching on-the-job, project participation and also in the User Groups.

Check the complete training program of the Holland Innovative Academy