The legacy of Magellan’s voyage proved beyond doubt that the planet was round, revolutionizing astronomy and geography, not to mention science and religion, in the process.
Today Medical device companies face a similar navigation challenge with an increasingly complex set of variables and spending millions to bring innovative products to market.
RegIQ believes there must be a better way. So, we introduce Magellan, the world’s first device compliance platform to help Medical Device companies navigate the complex environment of multiple jurisdictions, an ever-changing landscape of regulatory processes, new compliance and documentation requirements.
We invite you to explore the components of the platform that will improve your process and lower the historical costs of commercializing medical devices.
1) Login Screenshot
The Magellan platform can be accessed anytime from any web enabled device.
2) DASHBOARD Screenshot
Users are presented with a dashboard that gives an instant snapshot of where all the various projects are in the process of proceeding to market. The Dashboard can be completely customized around the organization’s requirements.
3) DEVICE MANAGER
The device manager stores all relevant information for new and existing device profiles for easy tracking and review. The information can be edited, and new devices added with a single click.
4) INTELLIGENCE MANAGER
The Intelligence Manager allows users to initiate a comprehensive search of all compliance requirements for any type and risk class of device, in over 100 countries around the globe with a simple click. The output is a highly detailed report, which includes all the required elements and attributes to support a submission for review by the relevant Competent Authority. Each search is catalogued and updated as requirements are changed or revised.
5) PROJECT MANAGER
The Project Manager allows the user to have a comprehensive view of all current projects. The intuitive interface makes it a simple ‘drag & drop’ to move a project through the various phases. Tasks, roles and timelines can be easily added to each project attribute as well as budget inputs, in tandem with the GTM Planner.
6) LICENSE MANAGER
This module stores all relevant information for existing device licenses for easy tracking and review. The idea is to keep all elements of the license current and when changes occurs from the Competent Authority or revisions are required, the module will send an alert to the user notifying them that action is needed. As a result, licenses are kept current and up to date.
7) DOCUMENT MANAGER
The Document Manager stores, tracks and retrieves all the documents which form part of the license file for a specific device and project.
8) GO TO MARKET PLANNER
The Go-To-Market Planner allows users to perform high level compliance searches for all types and risk classes of devices, which can be used for strategic and market planning purposes. 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. In simple terms, the GTM Planner helps users compare and determine market feasibility, based on compliance requirements against available resources.