MedTech Leading Voice, in collaboration with the Johner Institute, a globally recognized leader in medical device regulation, announced the launch of its new, free, nine-day course, “EUSTAR Regulatory Executive Management Program—Foundations of Medical Device Regulation.” Register now.

Designed for Busy MedTech Professionals 

EUSTAR offers a practical and efficient way to deepen their understanding of the EU Medical Device Regulation (MDR) as part of the broader (300+ training modules) Medical Device University (MDU) offered by the Johner Institute.

In response to the medical device industry's significant challenges in meeting the MDR's complex requirements, the Johner Institute is offering training to current professionals to address industry-wide talent shortages and resource constraints. 

This free course provides an opportunity to preview the robust resources available through the MDU.

Efficient Learning for Busy Professionals

The EUSTAR course is designed to fit seamlessly into the demanding schedules of MedTech professionals. 

The course takes approximately 15 minutes per day. Registrants receive a daily email that includes a video lesson and a self-assessment quiz. Each lesson is structured to explain the topic in detail, ensuring that participants gain a solid understanding of key regulatory concepts without overwhelming their schedules. 

Christian Johner, Owner of the Johner Institute, emphasized the course's accessibility and practicality: “Our goal is to train the next generation of regulatory executives, providing them with the knowledge and tools they need in a format that respects their time constraints. This program allows professionals to engage with our training in short, manageable sessions, helping them to train their teams and prepare for the future of the medical device industry.”

Course Content Overview

The course covers essential topics over its nine-day duration, including:

• Introduction to MDR: An overview of the regulatory landscape and its implications for medical device companies.
• Essential Requirements: In-depth coverage of general safety and performance requirements under the MDR.
• Classification and Conformity Assessment: Detailed guidance on device classification and the necessary conformity evaluation procedures.
• UDI & Eudamed: This section explains the new requirements for Unique Device Identification and the European database on medical devices (Eudamed).
• Clinical Evaluation & PMCF: Comprehensive coverage of clinical evaluation processes and post-market clinical follow-up requirements.
• Post-Market Surveillance: Strategies for ongoing monitoring and data collection to ensure device safety and performance.
• Roles and Responsibilities: Understanding the roles of manufacturers, importers, and authorized representatives under the MDR.
• Quality Management Systems: The impact of MDR on quality management systems, including changes to ISO 13485 and new requirements.

Additionally, this free course provides a valuable learning opportunity and allows participants to earn a certificate of completion, enhancing their credentials in medical device regulation.

Global Recognition and Expertise

The Johner Institute is renowned for its expertise in medical device regulation. Its team of 170 specialized consultants serves clients worldwide. The Institute’s comprehensive solutions, including the Regulatory Radar, post-market surveillance tools, and the “Fit for Future” digital transformation program, position it as a leader in the industry.

Prepare for the Future of MedTech

With the medical device industry evolving rapidly due to technological advancements and regulatory changes, companies must build a well-prepared and knowledgeable workforce. The Johner Institute’s free nine-day course offers a glimpse into the extensive training and resources available through the MDU, helping professionals stay competitive in this dynamic environment.

Visit the Johner Institute's website for more information.