Regulatory Affairs
Market access strategies
Just as many roads lead to Rome, there is no one right way to place a Medical Device on the market.
Table of contents: Strategies Market Access
Our services
- Development of a roadmap with possible strategies for the market access of your product in Europe.
- Creation of a framework plan with presentation of the necessary requirements.
- Presentation and discussion of the necessary work packages and cost points.
Our Market Access Workshop
In a Market Access Workshop / Assessment we will clarify the following questions, among others:
- Does the Medical Device have chances for a successfully completed conformity assessment procedure and thus for market access in the EU?
- How high are the costs for market access? Which work packages are necessary for this, such as clinical studies / tests?
- Evaluation of medical performance:
- What are the risks associated with the function of the Medical Device?
- How does the performance of the Medical Device compare to competitive products?
- Can the performance be proven based on literature data or does it require a clinical trial?
- What forms of reimbursement are possible? What needs to be done for this?
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