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a paradigm shift
from redefining the way devices are brought to market
from
Co 100 un trie s nt ete mp ty Co thori Au Intelligence Documentation Requirements Current Process • Disparate sources • Interdependent components Compliance Strategic Plan Knowledge Licenses • Resource intense • Vulnerable to requirement changes Risk • Costly Device Commercialization Next
Click on a number to display module detail Re-click the number to shrink and move to next module KNOWLEDGE PORTAL INTELLIGENCE PLANNER GO TO MARKETBUILDER This allows users to initiate a The Go To Market Manager allows INTELLIGENCE BUILDER comprehensive search of all users to perform high level • Comprehensive search of compliance requirements in 100 countries. compliance requirements for any compliance searches for all types and • All requirements for submission to risk classes of devices, which can be type and risk class of device, in competent authorities. used for strategic and market over 100 countries around the planning purposes. Key requirements globe. The output is a highly GTM PLANNER for a device submission to a relevant detailed report, which includes • Determine market feasibility Competent Authority are listed and all the required elements and based on compliance ROI can be calculated, based on requirements vs available attributes to submit an expected costs and timelines against resources. application for review by the forecast revenues. In simple terms, relevant Competent Authority. the GTM Planner helps users Each search is catalogued and determine market feasibility, based on compliance requirements against updated as requirements are available resources. changed or revised. Previous This module stores all relevant DOCUMENT MANAGER information for new and existing KNOWLEDGE PORTAL device licenses for easy tracking and • Repository for Device This module stores and tracks all review. The Knowledge Portal acts as Licenses. • Alerts to changes from documents which form part of a a centralized repository for all device competent authorities. device license. It integrates with the licenses and integrates with the • Integrates with Document Knowledge Portal, but can be Document Manager, if users Manager. subscribed to independently. Again, subscribe to that module. The idea is documents are kept current and any to keep all elements of the license DOCUMENT MANAGER changes or revisions that are current and when changes occurs • Stores and tracks documents required by the Competent from the Competent Authority or for license requirements. Authority, prompt an alert to be sent revisions are required, the module • ‘Push’ Alerts if changes made to the user for immediate action. by competent authorities. will send an alert to the user notifying them that action is required. Licenses are kept current and up o CENTRAL PROJECT MANAGEMENT TOOL date and users have easy access at any time. Track, Analyze, Report, Manage Resources Next 01 03 02 04
Click on a Zone to display included countries Re-click the Zone to shrink county display and move to next zone European Union 01 02 06 03 08 • Incentive for multiple zones 09 07 10 Previous Austria Belgium Bulgaria Croatia Cyprus Czech Republic Algeria Australia Denmark Belarus Argentina Bahrain Estonia. Zealand New Cameroon China Bosnia & Herzegovina Finland Bolivia Egypt Ethiopia Belize India Iceland Indonesia France Brazil Israel Rica Ghana Germany Costa Japan Lichtenstien Malaysia Chili Jordon Greece. Coast Ivory Cuba Kazakhstan Macedonia Philipines Hungary Colombia Kuwait Kenya Federation Dominican Russian Moldova Singapore Republic Ireland Equador Lebanon Nigeria. Korea Italy Salvador El South Norway Thailand Peru Morocco Latvia Africa South Guatamala Taiwan Serbia Vietnam Lithuania Uruguay Oman Tanzania Honduras Tajikistan Switzerland Luxembourg Venezuela Palestine Malta Nicaragua Uzbekistan Turkey Qatar Netherlands Panama Ukraine Poland Saudi Arabia Greece Portugal Tunisia Romania United Arab Emirates Slovakia Slovenia Yemen Spain Sweden Next United Kingdom Middle East Central. Africa & North America South America Oceania Europe. East North Model Business. America Southeast Sub-Saharan Africa Asia Caribbean Asia • Per Module pricing Canada • • Subscription based • USA • 10 Regions • Mexico 04 05 • • • • • • • • • • • • • • • • • • • • • • • • • •
1 2 3 Regular Platform Updates Available training & support Select modules & Regions Simple online sign up Previous Next
Device Companies Regulatory Managers Combined Process Cost Workflow Results Stable Cost Model Simplification / Organization Strategic Capabilities Customizable by module Enhanced Project Mgmt. In depth & timely reports Customizable by region Proactive Alert Push Greater Visibility 3 Distinct Benefit Streams Previous Next
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