Click to enlarge – The P1vital® PReDicT Test
WP1 Objectives:
- To further develop the P1vital® PReDicT Test to meet the functional, information security and regulatory requirements for successful deployment in WP2
- Implement modifications to the existing P1vital® PReDicT Test to allow for multi-language support including Dutch, French, German and Spanish
- Implement any modifications necessary to comply with the final clinical study protocol for WP2
- Install and test the P1vital® PReDicT Test and supporting infrastructure to ensure it performs as intended in the countries participating in the project and meets all the necessary regulatory requirements
- Conduct the necessary software validation activities and update all the necessary documentation to CE mark the P1vital® PReDicT Test as a Class I Medical Device, for use in the project
- Maintain and support the P1vital® PReDicT Test to ensure the successful completion of the project
WP1 Lead: Jonathan Kingslake
WP1 Partners:
- This work package is led by P1vital Products Ltd who will perform the project management, validation activities and produce all the validation documentation described below.
- P1vital Products Ltd will be supported by Elysium Ltd, a third party software provider, who will further develop the software and maintain the P1vital® PReDicT Test infrastructure and application during the project.
