The way you globally register medical devices Get ready……….. The way you globally register medical devices Is about to change!
redefining the way devices are brought to market from redefining the way devices are brought to market
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Current Process Disparate sources Interdependent components Documentation 100 Countries Competent Authority Intelligence Requirements Disparate sources Interdependent components Resource intense Vulnerable to requirement changes Costly Risk Compliance Strategic Plan Knowledge Licenses Device Commercialization
Device | License | Intelligence | Project | Document | Go To Market Future Process Documentation Strategic Plan Central Repository Seamless Integration Resource Efficient Web Enabled Customized Dashboard 6 Management Modules Intelligence Requirements Compliance Knowledge Licenses Device Commercialization Customized Dashboard Device | License | Intelligence | Project | Document | Go To Market
Custom Dashboard Configured by customer Customized Dashboard Configured by customer Instant snapshot of all activity Customize on the fly Management Modules Device License Intelligence Project Document GTM
Device Manager New & existing profiles All information easily edited Customized Dashboard New & existing profiles All information easily edited New devices added with single click Management Modules Device License Intelligence Project Document GTM
License Manager All information for each license Customized Dashboard All information for each license Proactive alert notification of changes by Competent Authority New licenses added with single click Management Modules Device License Intelligence Project Document GTM
Intelligence Manager Comprehensive requirement search Customized Dashboard Comprehensive requirement search 10 global regions Searches catalogued and updated as requirements change Management Modules Device License Intelligence Project Document GTM
Project Manager Comprehensive view of current projects Customized Dashboard Comprehensive view of current projects Drag & Drop to move projects through phases Tasks, Timelines, Budget inputs Works with Go To Market Planner Management Modules Device License Intelligence Project Document GTM
Document Manager Customized Dashboard Stores, tracks and retrieves all the documents which form part of the license file for a specific device and project. Interdependent components Management Modules Device License Intelligence Project Document GTM
GTM Planner High level compliance searches Strategic & Market planning Customized Dashboard High level compliance searches Strategic & Market planning Determine market feasibility Management Modules Device License Intelligence Project Document GTM
Business Model All modules included Subscription based 10 Regions 01 04 05 02 08 06 09 07 03 10
3 SaaS Subscription Models Early Stage STARTUP All Modules 3 Regions 2 User licenses $15,000 USD/Annually Most Popular PROFESSIONAL All Modules 6 Regions 5 User licenses $20,000 USD/Annually Global Coverage ENTERPRISE All Modules 10 Regions 10 User licenses $25,000/USD/Annually 3 SaaS Subscription Models
2 1 3 Ongoing Service/Support/Updates Get Started! Select Plan Simple online sign up
3 Distinct Benefit Streams Device Companies Cost Stable Cost Model Customizable by module Customizable by region Regulatory Managers ProActive Management Simplification / Organization Enhanced Project Mgmt. Proactive Alert Push Combined Process Results Strategic Capabilities In depth & timely reports Greater Visibility 3 Distinct Benefit Streams
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