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Mastering EU MDR: Navigating Compliance for Medical Devices
Length of Course
2 Days
Deliver Method
Classroom
Materials
Each participant will receive a training manual
Certificate of Completion
A certificate of completion will be issued on successful course completion.
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.
On completion of this training, participants will be able to:
- Understand the EU MDR’s scope and regulatory framework: Articulate the key principles, requirements, and implications of the European Medical Device Regulation, and identify how it differs from the previous Medical Device Directive (MDD).
- Classify medical devices and assess their conformity: Determine the appropriate classification of medical devices under EU MDR and comprehend the conformity assessment procedures necessary to achieve compliance.
- Comply with labeling and Unique Device Identification (UDI) requirements: Comprehend the labeling and UDI obligations under the EU MDR, and apply best practices to ensure accurate and compliant product identification.
- Navigate post-market surveillance and vigilance reporting: Develop a systematic approach to post-market surveillance, including the identification and reporting of adverse events, ensuring compliance with EU MDR’s vigilance requirements.
- Master clinical evaluations and performance studies: Gain insights into the EU MDR’s impact on clinical evaluations and performance studies, and acquire strategies to meet the new evidence-based requirements.
- Throughout the course, participants will engage in interactive activities, real-world case studies, and practical exercises, empowering them to confidently address the challenges of EU MDR compliance and become catalysts for regulatory excellence within their organizations. The customized in-company approach will ensure the course is directly relevant to the specific needs and context of the company, maximizing the value and applicability of the training.
This exclusive in-company training course, “Mastering EU MDR: Navigating Compliance for Medical Devices,” is specifically tailored for professionals working within your medical device company. The course is essential for individuals across various departments and roles, aiming to equip your team with the knowledge and skills necessary to excel in the ever-changing regulatory landscape of the European Medical Device Regulation (EU MDR). Participants from your organization who will benefit from this course include:
Regulatory Affairs Team: Regulatory affairs professionals responsible for interpreting and implementing EU MDR requirements, ensuring seamless compliance, and maintaining market access for your medical devices.
Quality Assurance and Quality Control Specialists: QA/QC experts who play a crucial role in establishing and maintaining robust quality management systems that align with EU MDR standards.
Research and Development Teams: Engineers, scientists, and researchers involved in designing and developing medical devices, as they need to be well-versed in EU MDR’s safety and performance criteria.
Clinical and Medical Experts: Healthcare practitioners and medical professionals involved in clinical evaluations and performance studies, aiming to meet the EU MDR’s evidence-based requirements.
Product Managers and Life Cycle Managers: Professionals overseeing medical device portfolios, responsible for ensuring compliance throughout the entire product lifecycle.
Compliance Officers and Auditors: Team members responsible for conducting internal audits and assessments to ensure conformity with EU MDR regulations.
Supply Chain and Procurement Personnel: Individuals involved in sourcing medical devices and assessing suppliers’ compliance with EU MDR to maintain a robust supply chain.
Notified Body Liaison Officers: Employees engaged in interactions with Notified Bodies during the certification process, working to foster successful cooperation for timely approvals.
Legal and Regulatory Consultants (if applicable): External experts who collaborate with your company on EU MDR compliance, ensuring they stay updated with the latest regulatory developments.
Senior Management and Decision-Makers: Executives and stakeholders who steer the strategic direction of your medical device company, benefiting from a comprehensive understanding of EU MDR’s impact on business operations and future product plans.
As an in-company course, the content and examples will be customized to address your company’s specific product portfolio, internal processes, and unique challenges. By bringing your team together in this focused and collaborative learning environment, we aim to empower them with practical insights and actionable knowledge that can be immediately applied to enhance compliance, streamline processes, and drive overall business success within the dynamic EU regulatory landscape.