Preferred learners
- Anywhere
- Academic experience
Categories
Project scope
- What is the main goal for this project?
-
The main goal for the project is to ensure that Provista AI's Computer-Aided Detection software for the early detection of prostate cancer is compliant with global regulatory standards. This will involve working with regulatory bodies to obtain necessary approvals and certifications for the software to be used in different regions around the world.
- What tasks will learners need to complete to achieve the project goal?
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Tasks that learners need to complete to achieve the project goal include:
- Researching and understanding the regulatory requirements for medical diagnostic software in different global regions.
- Collaborating with the development team to ensure that the software meets the necessary standards and requirements.
- Compiling and submitting the required documentation for regulatory approvals and certifications.
- Communicating with regulatory agencies to address any inquiries or concerns related to the software.
- Monitoring and staying updated on changes in regulatory requirements to ensure ongoing compliance.
Final deliverables should include:
- Documentation of the regulatory requirements for different global regions.
- Documentation of the software's compliance with the regulatory standards.
- Records of communication with regulatory agencies and any approvals or certifications obtained.
- What is the main goal for this project?
-
The main goal for the project is to ensure that Provista AI's Computer-Aided Detection software for the early detection of prostate cancer is compliant with global regulatory standards. This will involve working with regulatory bodies to obtain necessary approvals and certifications for the software to be used in different regions around the world.
- What tasks will learners need to complete to achieve the project goal?
-
Tasks that learners need to complete to achieve the project goal include:
- Researching and understanding the regulatory requirements for medical diagnostic software in different global regions.
- Collaborating with the development team to ensure that the software meets the necessary standards and requirements.
- Compiling and submitting the required documentation for regulatory approvals and certifications.
- Communicating with regulatory agencies to address any inquiries or concerns related to the software.
- Monitoring and staying updated on changes in regulatory requirements to ensure ongoing compliance.
Final deliverables should include:
- Documentation of the regulatory requirements for different global regions.
- Documentation of the software's compliance with the regulatory standards.
- Records of communication with regulatory agencies and any approvals or certifications obtained.
- How will you support learners in completing the project?
-
Students will have access to core members of our development team. A SPOC will be made available for meetings upon request.
- What skills or technologies will help learners to complete the project?
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Skills needed to successfully complete the project include:
- Knowledge of global regulatory affairs for medical devices or software.
- Understanding of medical device regulations and standards such as FDA, CE Marking, and other international standards.
- Strong communication and documentation skills.
- Attention to detail and ability to work in a highly regulated environment.
Supported causes
About the company
- https://provista.ai
- 11 - 50 employees
- Hospital, health, wellness & medical
Provista AI, a nascent North American venture, is revolutionizing prostate MRI interpretation through our advanced Computer-Aided Detection prostate software. Merging artificial intelligence with radiological expertise, we provide radiologists with a robust tool that accelerates the diagnostic process. Powered by deep neural networks, our software analyzes every pixel of imaging data to deliver critical insights swiftly, amplifying diagnostic accuracy and enabling swift and precise cancer identification. It optimizes workflow efficiency, providing a smoother operational rhythm for radiologists. Provista AI ensures consistent excellence in diagnostics, pioneering a standard of uniformity in analysis.
Step into a realm where efficiency, accuracy, and standardization define the zenith of patient care. Provista AI is driving the healthcare sector toward a future of improved patient care and superior diagnostic outcomes by alleviating the analysis workload and propelling the standard of prostate cancer diagnosis.