Training Features

EU MDR 2017/745: Basics for Non-Regulatory Staff at Medical Device Manufacturers

Gain a clear understanding of MDR and how it impacts your role with this practical training for non-regulatory staff.
Format

Virtual Training

Level

Basic

Date

13 January 2026

Time

15:00 - 17:00 CET

Duration

2 hours

Trainer

Gert Bos

Certificate

Certificate included

Price

€ 295 or equivalent currency

MDR Training for Non-Regulatory Staff

The Medical Device Regulation (MDR) 2017/745 introduces stricter requirements for medical devices, impacting all departments within a medical device company—not just regulatory teams. A basic understanding of MDR is essential for ensuring company-wide compliance and avoiding regulatory pitfalls. 

Led by Gert Bos, this interactive training helps non-regulatory staff understand how the MDR affects their roles. This course covers the key principles, impact on daily operations, and essential compliance aspects in a clear and practical manner. Participants will receive a certificate upon completion, confirming their understanding of MDR fundamentals.

Training Overview
Agenda
Key Learning Objectives
What is included?
Training Dates
Who Should Attend?
Training Overview
The Medical Device Regulation (MDR) 2017/745 sets stricter requirements for medical devices and affects all departments within a company, not only regulatory teams. A solid understanding of MDR is vital to avoid compliance risks and ensure smooth daily operations.

This training is designed for non-regulatory staff and explains in practical terms how MDR impacts various roles across the organization. Participants will gain clear insights into MDR principles, compliance essentials, and their role in supporting regulatory success. A certificate of completion will be provided to confirm their understanding of MDR fundamentals.
Key Learning Objectives
  • Understand the purpose and impact of the MDR on medical device manufacturers.
  • Learn how different company departments are affected by MDR requirements.
  • Gain basic knowledge of device classification, CE marking, and conformity assessment.
  • Understand the importance of technical documentation and product safety data.
  • Learn how marketing, sales, manufacturing, and other non-regulatory teams contribute to compliance.
  • Recognize key regulatory terms and processes to improve cross-department collaboration.
  • Identify best practices for supporting MDR compliance in your daily work.
What is included in this live virtual training?
  • Direct access to an expert trainer
  • Interactive and engaging training session
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Training Dates
This training is delivered in one session, lasting 2 hours, providing a focused and efficient learning experience. The sessions will take place on 13 January 2026, allowing participants to absorb key information between training days while minimizing disruption to their daily work.

If this training date is not suitable, additional sessions will be held in 2026. More information will be shared soon.
Who Should Attend?
  • R&D engineers and product development teams.
  • Manufacturing, supply chain, and operations staff.
  • Sales, marketing, and commercial teams.
  • Customer service and complaints-handling professionals.
  • Quality Assurance (QA) professionals new to MDR.
  • Anyone working at a medical device company who needs a foundational understanding of MDR compliance.
Customized Team Training
We offer fully tailored team training programs designed around your specific products, processes, technologies, and challenges, ideal for addressing unique training needs or accommodating larger groups. Learn More.
Topics Discussed in the Training
  • Regulatory Framework & Why It Matters: Understand the key differences between MDR and MDD, the importance of compliance across all departments, and the impact of regulatory requirements on company operations. 
  • Key MDR Requirements & Their Impact on Daily Work: Learn the classification of medical devices, the significance of CE marking and product certification, and the roles of Notified Bodies and Competent Authorities in the regulatory process.
  • R&D & Engineering: Design controls, risk management, and usability
  • Manufacturing & Supply Chain: Supplier requirements and product traceability 
  • Sales & Marketing: Advertising claims, labeling, and promotional restrictions
  • Customer Service & Complaints Handling: Post-market surveillance and incident reporting 
  • Technical Documentation & Product Compliance: Understand the importance of technical documentation, the role of clinical evaluation and safety data in product approval, and the fundamentals of post-market surveillance and vigilance reporting.
  • How to Support Compliance in Your Role: Identify MDR-related tasks in daily operations, enhance communication with the regulatory team, and avoid common mistakes that could lead to non-compliance.

Flexible Online Training Designed for MedTech Professionals

Participate from anywhere with our interactive virtual format, designed to fit your schedule while delivering in-depth, actionable content tailored to real-world regulatory challenges.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

Learn directly from regulatory experts with practical industry experience and gain clear, actionable insights into navigating x.

Expert-Led Training for Practical Compliance

Meet the Trainer

Gert Bos

Gert has 26 years of experience in life sciences (devices and pharma), in university, industry, 4 Notified Bodies, and in strategic regulatory and business consulting.
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