The project goals for Ora-3D's assistive oral care solutions in the elder care market encompass a comprehensive strategy that aims to address the unique needs of this demographic. Ora-3D is committed to enhancing the quality of life for seniors through innovative medical devices. The primary focus of this project is to provide a detailed report that covers various aspects of research, analysis, insights, and recommendations related to Class I and Class II medical devices. The overarching objectives are aligned with the following key areas:

1. Strategic Regulatory Affairs: The project seeks to establish a robust regulatory strategy for Ora-3D's assistive oral care devices. This involves thorough research into regional and international regulatory frameworks to ensure compliance and smooth market entry.
2. Classification and Combination Product Approvals: The project aims to determine the appropriate classification for Ora-3D's devices and explore potential combination product approvals, where applicable. This involves a meticulous analysis of the devices' components and functionalities.
3. Global Commercialization: The project's goal is to devise a comprehensive plan for the global commercialization of Ora-3D's products. This includes identifying target markets, understanding cultural nuances, and strategizing market entry and expansion.
4. Clinical Research: The project aims to advance Ora-3D's devices through well-designed clinical research. This involves defining the scope of clinical trials, establishing protocols, and ensuring ethical considerations are met.
5. Clinical Trial Design: Detailed attention will be given to the design of clinical trials for Ora-3D's products. This encompasses defining endpoints, patient populations, and methodologies to ensure robust data collection and analysis.
6. Clinical Operations: The project will outline the operational aspects of conducting clinical trials, including site selection, patient recruitment, data monitoring, and ensuring adherence to protocols.
7. Regulatory Compliance: Regulatory compliance is of paramount importance. The project seeks to ensure that all clinical trials and subsequent product releases adhere to relevant regulatory guidelines and requirements.
8. Adverse Event Profiling: A comprehensive strategy for monitoring and profiling adverse events associated with the use of Ora-3D's devices will be established. This involves creating protocols for reporting and analyzing adverse events.
9. Risk Evaluation and Mitigation Strategies (REMS): The project will identify potential risks associated with Ora-3D's devices and propose strategies to mitigate them. This ensures the safety and well-being of users.
10. Post Market Surveillance: The project aims to establish a robust post-market surveillance system that enables continuous monitoring of device performance, user feedback, and potential issues in real-world usage.

Through the successful execution of these project goals, Ora-3D aims to create a strong foundation for its assistive oral care solutions in the elder care market. The resulting detailed report will serve as a roadmap for Ora-3D's growth strategy, ensuring regulatory compliance, clinical efficacy, and overall market success.

Project deliverables include:

1. A 10-15 minute presentation on key findings and recommendations
2. A detailed report including their research, analysis, insights and recommendations

• Routine Calls and Communication
• Access to Internal Team Resources
• Introduction to Product and Vision Roadmap
• Access to Entrepreneurship Training Programs* (Potentially)