New EU Medical Device Regulations (EU MDR) Training

  • Overview
  • On-Site Training
  • Who Should Attend?
  • Trainer Profile

The European regulatory landscape is changing quickly, becoming stricter and more technically challenging for medical device companies. With major changes to device classification, and requirements for technical documentation and clinical evidence, companies will need new EU medical device regulations (EU MDR) training. Planning ahead ensures an organization understands the requirements and has the appropriate resources in place.

On-Site Training

NSF’s on-site courses are designed to help students interpret and plan for the EU regulatory changes with particular focus on their impact both operationally and strategically. Through our wide range of courses, you will learn about the strategic and business elements that companies may face when preparing for and implementing the new regulation.

These course offerings are highly interactive, instructor-led training ranging from one to five days. Our medical devices training courses are designed to include case studies, student tasks, hands-on exercises and small group break-out sessions to help attendees understand, interpret and plan for the EU regulatory changes. We strive to ensure our students gain a better understanding of the regulations and prepare for the changes affecting their companies. Upon the completion of a course, students will receive a Certificate of Successful Completion, to be added as part of the employee’s competency training file.

Our offer of new EU MDR training courses includes:

EU MDR – Strategic Planning for the Coming Changes
In this two-day course, students learn the detailed structure of the regulation via a step-by-step guide of the regulation’s chapters and annexes. Students will gain better knowledge of the regulation to help plan their gap analysis approach, including getting started tips, timelines and more, while also gaining knowledge into the impacts of Brexit.

EU MDR – Technical File Academy
In this four-day course, students learn the technical documentation requirements, including pre-clinical review specifics, safety and performance, risk management, harmonized standards use, auditing and others associated with the EU MDR, as well as the notified body review requirements. Students also learn how to conduct a technical review, develop a post-market surveillance plan and report nonconformities.

CQI/IRCA Certified Lead Auditor Course – Incorporating ISO 1385:2016 and MDSAP (and EU MDR Requirements*)
In this five-day course, students plan, conduct, report and follow up on a QMS audit in accordance with ISO 13485:2016, MDSAP and EU MDR requirements. Students learn how to apply MDSAP auditing strategies, adopted by Auditing Organizations in the MDSAP program, and to identify and grade nonconformities and prepare an audit report in accordance with MDSAP criteria.

*This course is currently certified to include ISO 13485:2016 and MDSAP requirements. Inclusion of EU MDR requirements in the accreditation is pending. Therefore, students will receive two certificates upon successful completion of this course:

  • Certificate of Successful Completion – CQI/IRCA QMS Lead Auditor Based on ISO 13485:2016 and MDSAP Requirements (with passing score, to be filed with CQI/IRCA)
  • Certification of Successful Completion – NSF International EU MDR Requirements

EU MDR – Internal Auditor Training
In this two-day course, students learn how to prepare for the upcoming changes from the MDD to the MDR. Students will learn how to audit program management (including preparation of internal audit plans) and how to address gaps during the audit. This course also focuses on understanding ISO 13485:2016 relative to the EU MDR and how companies can be prepared.

Who Should Attend?

This class is useful for all management and executive personnel with responsibility for medical device regulatory lifecycles, involvement with the design and implementation of quality management systems, or involvement with product design and development.

Trainer Profile

NSF's medical devices training courses are taught by experts who have years of experience in medical device quality standards and regulatory requirements. Our trainers are committed to creating a learning environment that is highly interactive and based on real scenarios to help you apply practices and improve behaviors within your workplace. Learn more about our trainer for this course:

Upcoming Courses & Webinars

In New EU Medical Device Regulations (EU MDR) Training
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