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The Power of the EU AI Act and the MDR
With the introduction of the EU AI Act and the Medical Device Regulation (MDR), companies in the...
Develop a pragmatic and wide approach as a MedTech professional
Having a fantastic, innovative idea developed by enthusiastic people in the MedTech field is great. However, most companies forget about the correct set-up to deliver their products to the market.
Be the professional that will be able to create the technical documentation at a stage prior to the development process, improving the technical implementation as well as quality and regulation.
Develop a broad vision as a MedTech professional.
Regulations and Standards
Understand the essence of regulations and know how the standards are used in order to comply to them. Know the core of all relevant quality, safety, and risk management standards and how those interact, in order to apply them pragmatically in your project.
Project Management
We will not only show you the gaps with which you have to comply, but we will also help you to set up a project approach to help you and your team to comply within time and budget.
In-depth knowledge
We provide in-depth courses on challenging topics such as Clinical Evaluation, Medical Device Software Development, and discovering the needs of your customer and translating those into measurable requirements. For every course counts that it is a mix of theory and hands-on practice, with templates for you to apply the knowledge during and after the course.
“In order to put good and safe products on the market, it is necessary to plan certain activities in time during the design and production process. For example, performing a risk analysis, writing a plan for testing the product, or a user analysis to determine the critical parameters for the product.”
Courses for MedTech Professionals.
HI-MT1 Fundamentals in Medical Device Development
MedTechLearn how the expertises regulatory, design for six sigma and project management cooperate as a team to successfully complete the design of the medical device.
Wim Schouten
Sr. Project Manager
- 3 days
HI-MT2 Medical Devices - Getting started with CE Certification
MedTechGet an overview of the regulatory requirements and learn how to implement these in your development process.
Lisette van Steinvoren - Stamsnijder
Competence Lead MedTech & Sr. Project Manager Medical
- 1 day
HI-MT8 Clinical Evaluation and Data analysis – for Medical Devices
MedTechDesigned for medical device professionals, this training increases knowledge and understanding of clinical evaluation and post-market surveillance (PMS), and enables you to integrate clinical evaluation into your product development processes.
Monique van Lier
Medical Device Development Expert
- 1 day
HI-MT3 In Vitro Diagnostic Medical Devices - Getting started with CE Certification
MedTechGet an overview of the regulatory requirements and learn how to implement these in your development process.
Lisanne Karbaat
Regulatory Affairs Expert IVDR
- 1 day
HI-MT7 Voice of the Customer – Getting started with requirements
MedTech
Improve your customer satisfaction and loyalty. Learn how to translate the Voice of the Customer into Critical to Quality parameters!
Lisette van Steinvoren - Stamsnijder
Competence Lead MedTech & Sr. Project Manager Medical
- Half a day
HI-MT4 Software as Medical Device - Getting started with CE Certification
MedTech
A practical guide on the application of MDR requirements for Medical Device Software.
Nico van Oene
QA/RA Consultant
- 1 day
Partnerships with higher education institutions
Together with recognized institutes such as the TechMed Center at the University in Enschede, IBIS University Amsterdam, University of Stuttgart, and the Delft University of Technology, we offer courses and certification.
At Holland Innovative, we believe that the plurality of knowledge channels is vital to keep up to date. Therefore, it is essential for us to maintain academic partners to exchange people, ideas, and methods.
Personal development will take you further
All our courses are unique and directly related to daily challenges and projects. We immediately switch to the demands and needs of our customers and their employees, so that every training is custom-made.
Our experienced professionals can identify areas for personal growth and define a clear plan to reach your full potential.
Get started and save your seat.
Take the next step in your personal development.
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