MDR & IVDR Training
Navigate MDR and IVDR regulations, covering clinical evaluation, risk management, and post-market surveillance for EU compliance.
Overview
The Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) are critical frameworks established by the European Union to ensure the safety and effectiveness of medical devices and in vitro diagnostic products. Understanding these regulations is essential for professionals involved in the development, approval, and marketing of medical devices in Europe. Our MDR & IVDR Training provides a comprehensive overview of these regulations, covering key requirements, compliance pathways, and the implications for manufacturers and stakeholders in the medical device industry. Participants will gain insights into risk management, clinical evaluation, post-market surveillance, and the roles of Notified Bodies.
Benefits of Attending
- Understand the key requirements and timelines associated with MDR and IVDR compliance.
- Learn about the differences between the previous directives and the new regulations, including changes in classification and conformity assessment processes.
- Gain practical knowledge on conducting clinical evaluations and post-market surveillance to ensure ongoing compliance.
- Explore strategies for effective communication with Notified Bodies and regulatory authorities throughout the approval process.
- Stay informed about best practices for maintaining compliance in a rapidly evolving regulatory landscape.
Who Should Attend?
This training is ideal for:
- Regulatory affairs professionals responsible for ensuring compliance with MDR and IVDR requirements.
- Quality assurance specialists involved in the development and maintenance of quality management systems for medical devices.
- Clinical research professionals conducting evaluations related to medical devices and diagnostics.
- Product managers and marketers seeking to understand regulatory implications for product launch strategies.
- Executives and business leaders aiming to align their organisations with current EU regulations in medical device development.
Comprehensive, Expert-Led Training Hub
Gain industry-leading insights with structured, interactive courses designed to simplify regulations, enhance compliance, and drive industry best practices.
