Regulatory Requirements Landscape Analysis for a Cardiovascular Medical Device
Task:
Assess the feasibility of accessing 9 EU countries with an innovative cardio medical device.
Task:
Assess the feasibility of accessing 9 EU countries with an innovative cardio medical device.
Client:
Global Medical Technologies Company
Region:
9 CEE and EU countries
Deliverables:
A detailed report on the market sizes, competition, number of patients (existing and new per year), and regulatory and market access requirements.
Countries in scope:
Slovakia, Slovenia, Greece, Bulgaria, Hungary, Latvia, Estonia, Lithuania, Ukraine
Project scope:
- Assessment of the reimbursement scope across 8 EU countries and Ukraine.
- Estimation of the number of potential accounts for the device.
- Estimation of the market size for the device in each country.
- Competitive analysis.
- Assessment of regulatory requirements for market entry.
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