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Mastering EU MDR: Navigating Compliance for Medical Devices
Level of Difficulty
Beginner (no knowledge at all of the topic).
In this comprehensive in-company training course, we delve into the intricacies of the European Medical Device Regulation (EU MDR) and equip participants with the knowledge and skills necessary to navigate the evolving regulatory landscape effectively. With the EU MDR’s recent implementation, medical device manufacturers and stakeholders face new challenges in ensuring compliance and maintaining market access. This course is designed to empower your team with a deep understanding of the EU MDR’s key requirements, timelines, and obligations, enabling them to confidently adapt to the changes and remain at the forefront of regulatory compliance.
The course will cover essential topics such as the scope and classification of medical devices under EU MDR, conformity assessment procedures, post-market surveillance and vigilance reporting, labeling and Unique Device Identification (UDI) requirements, and the role of the Notified Bodies in the certification process. Our expert instructors will also address the implications of EU MDR on clinical evaluations, performance studies, and the transition from the Medical Device Directive (MDD) to the EU MDR.
Through interactive discussions, real-world case studies, and practical exercises, participants will gain insights into best practices for preparing and submitting technical documentation, including Clinical Evaluation Reports (CERs) and Post-Market Surveillance (PMS) plans, to meet the rigorous EU MDR standards. Additionally, we will explore strategies for successful cooperation between internal teams, competent authorities, and Notified Bodies, ensuring seamless conformity throughout the entire product lifecycle.
As an in-company training program, we recognize the unique needs and context of your organization. Therefore, our expert trainers can tailor specific modules or examples to address your company’s particular product portfolio, processes, and challenges. This customized approach aims to maximize the value of the training, ensuring that your team gains practical insights and actionable knowledge that can be readily applied to enhance compliance and drive business success within the dynamic EU regulatory landscape.