This comprehensive bundle combines training on Requirements of the Medical Device Regulation (MDR), Technical Documentation and Conformity Assessment for Medical Devices, and Post-market Surveillance and Vigilance under MDR and IVDR. Designed for medical device professionals responsible for regulatory compliance, quality management, product development, and market access, this bundle provides practical insight into the key requirements and processes needed to successfully place and maintain medical devices on the European market.

Participants will explore the core requirements of the MDR, including device safety and performance, conformity assessment, technical documentation, post-market surveillance (PMS), vigilance reporting, transparency, traceability, and regulatory responsibilities across the product lifecycle. The bundle also addresses the role of manufacturers, importers, distributors, authorized representatives, and notified bodies within the European regulatory framework.

Through these courses, learners will gain insight into how organizations can:

• Understand and apply key EU MDR regulatory requirements
• Develop and maintain compliant technical documentation
• Navigate conformity assessment processes and notified body expectations
• Establish effective post-market surveillance and vigilance systems
• Support product lifecycle compliance and market access activities
• Integrate MDR and IVDR requirements into quality management systems

Who Should Attend?

This bundle is ideal for:

• Regulatory Affairs Professionals
• Quality Assurance and Quality Management Personnel
• Medical Device Manufacturers
• Product Development and Engineering Teams
• Clinical and Compliance Professionals
• Importers, Distributors, and Authorized Representatives
• Individuals responsible for MDR implementation and regulatory compliance

Learning Outcomes

Upon completion, participants will be able to:

• Describe the key requirements and principles of the EU Medical Device Regulation (MDR).
• Understand the conformity assessment pathways required for market access.
• Develop and maintain technical documentation that demonstrates regulatory compliance.
• Explain the requirements for post-market surveillance and vigilance activities under MDR and IVDR.
• Understand the relationship between regulatory requirements and quality management systems.
• Recognize the roles and responsibilities of stakeholders involved in medical device compliance.

Bundle Benefits

• Gain a comprehensive understanding of EU MDR regulatory requirements
• Learn how to create and maintain compliant technical documentation
• Understand conformity assessment processes and notified body expectations
• Develop knowledge of post-market surveillance and vigilance requirements
• Strengthen your ability to support compliance throughout the medical device lifecycle
• Build confidence in navigating European medical device regulatory obligations

Whether you are new to medical device regulatory affairs or looking to strengthen your understanding of EU MDR requirements, this bundle provides the essential knowledge needed to support regulatory compliance, maintain market access, and contribute to the safety and performance of medical devices.