- 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.
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.

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
Theo de Goede
Sr. Project Manager & Master Black Belt
Lisette van Steinvoren - Stamsnijder
Competence Lead MedTech & Sr. Project Manager MedicalCourse information
- Eindhoven/Enschede
- 3 modules of 1 day
- 15/05, 06/06, 27/06
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.
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 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
Yes, I'm joining.
What you’ll learn.
Block 1 - day 1/3
What you'll learn on day 1, day 2 and day 3 of the course
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)
Dates 2023
Session I Enschede:
Day 1: 15 May
Day 2: 6 June
Day 3: 27 June
Session II Eindhoven:
Day 1: 2 October
Day 2: 12 October
Day 3: 9 November
Group size
A maximum of 10 participants
Relevant courses.
HI-MT2 CE Certification of your Medical Device
MedTechGet an overview of the regulatory requirements and learn how to implement these in your development process.

- Enschede
- 1 module of 1 day
- June 7 - June 7




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