EMPOWERING MEDICAL DEVICE COMPANIES
The Magellan platform consists of 4 innovative modules to achieve regulatory intelligence.
Comprehensive search of compliance requirements for all device types and risk classes, globally. Delivers a highly detailed report that includes all required elements and attributes to submit an application for review by the Competent Authority which is then catalogued and updated as requirements are changed or revised.
User-friendly, centralized repository that stores all relevant information for new and existing device licenses for easy tracking and review. Tracks and alerts users when changes are made by the Competent Authority or revisions are required, ensuring the license is always up to date. Is integrated with Document Manager.
Perform high level compliance searches for all types and risk classes of devices, helps users determine market feasibility, based on compliance requirements against available resources. Key requirements for a device submission to a relevant Competent Authority are listed and ROI can be calculated, based on expected costs and timelines against forecast revenues.
Stores and tracks all documents required on a device license, Document Manager integrates with Knowledge Portal.
MAGELLAN PLATFORM BENEFITS
There are 3 distinct benefit streams from implementing the Magellan Platform as the cornerstone to your Device Commercialization strategy & process.