Advanced Medical Device Development

Delve into the critical stages of medical device development with this advanced course, building upon your existing knowledge. This program focuses on the pivotal events after design freeze, guiding you through clinical evaluation and successful commercial launch.

A strong emphasis is placed on Quality Systems and Manufacturing best practices, ensuring regulatory compliance and adherence to design concepts.

The course begins by expanding your understanding of US regulatory knowledge to encompass the fundamentals of medical device regulation in the EU. We'll specifically explore the Medical Device Regulation (MDR) and In Vitro Devices Regulation (IVDR).

Next, we'll navigate post-design activities, including completing the Design History File (DHF) and initiating the initial steps towards commercialization.

Learn how to effectively manage device changes after market entry. We'll cover methods for implementing these changes and validating new processes to ensure continued quality and safety.

Finally, gain a comprehensive understanding of post-market activities, focusing on Product Management and clinical trials. This includes a detailed examination of the regulations for conducting human studies, and the crucial role of the Product Manager in orchestrating these activities for a successful product lifecycle.

This course is ideal for professionals seeking to master the complexities of bringing medical devices to market and maintaining compliance throughout their lifecycle.