Course information

  • 1 day
  • 16 September 2025

Investment

The investment is €795,- per participant (ex. VAT).

Included are templates, the course material, beverages and lunch.

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HI-MT6: MDR & IVDR for Suppliers

Under the new legislation, the Medical Device Regulation (MDR 2017/745) & In-Vitro Diagnostic Medical Device Regulation (IVDR 2017/746), manufacturers of medical devices are required to have sufficient information and control over the entire supply chain, including all suppliers of critical components. To meet this requirement as a supplier, it is essential that you understand and
apply the core of the MDR and IVDR within your company.

Our interactive workshop will give you with a clear overview of the relevant regulations and standards important for your role in the MedTech sector. You will know what is required, and how to make your documentation and processes in line with the applicable laws and regulations. This will ensure that your customers’ products are MDR/IVDR compliant, thereby strengthening your position in the sector.

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Learnings


  • Gain a clear understanding of the MDR and IVDR regulations.
  • Learn how to implement compliance practices within your organization.
  • Discover best practices for risk management and stakeholder engagement.
  • Understand the significance of maintaining compliance to enhance product quality and safety.

Teaching professionals.

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.
Monique van Lier

Monique van Lier

Medical Device Development Expert
Monique is a Medical Device Development Expert, with a special focus on clinical evaluation, clinical application training, and post market surveillance. As a pragmatic team player with a result-oriented mindset, Monique is committed to involve users in the product development process.

Results

By attending this training, you will gain invaluable insights and practical tools that enable you to navigate the complexities of MDR and IVDR compliance. You'll learn how to effectively meet regulatory requirements while ensuring that your products align with market needs. This training will equip you to enhance your organization’s compliance strategy, ultimately leading to improved product quality and a better experience for your customers.

 

MDR & IVDR for Suppliers

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What you'll learn

Course Content

This course offers a blend of theory and practical application focused on the requirements of MDR and IVDR compliance, essential for the Medtech industry.

In this workshop, you will not only explore the fundamental principles of these regulations but also gain hands-on experience with best practices for ensuring compliance. You’ll learn how to effectively engage with stakeholders, conduct thorough assessments, and translate regulatory requirements into actionable insights for your product development process.

 

Practical information.

For whom

This training is ideal for professionals working in the Medtech supply chain, including:

• Development teams
• Process engineers
• Project managers
• Sales managers
• Quality managers
• Members of the management team

 

Prerequisites:
• Professionals with at least a 
bachelor’s degree or equivalent 
knowledge gained through 
experience.
• Knowledge of the CE certification 
process, MDR/IVDR, quality 
management system, or standards 
is not required

Certificate
After completing the course, participants receive proof of participation. 

Location & Dates

Location
Enschede – The Gallery, Hengelosestraat 500

Dates 2025
14 May 2025

16 September 2025

Group size 

A maximum of 10 participants