Eurofarm offers customized product research and development service according to customer requirements.
The activity can be carried out either by adapting Eurofarm product lines that already have CE or FDA marking, or by designing and developing new medical devices.
In the development of a new medical device, Eurofarm is able to assist its client in the entire development process, from the definition of the product concept to the registration in Europe and worldwide and the subsequent launch of the product on the market.
The implementation of a development project for a medical device follows a rigorous and systematic process to ensure safety, effectiveness and regulatory compliance. Here are the main steps
1. Technical-economic feasibility
Definition of the Clinical Problem: Concept definition and technical-economic analysis for COG processing
Feasibility Study: Evaluate the technical, financial and regulatory feasibility of the project.
Product Specifications: Define the functional and non-functional requirements of the device.
Project Planning: Establish a detailed plan with timeline, budget and resources needed.
2. Design and Development
Conceptual Design: Create conceptual drawings and prototypes of the device.
Prototyping: Build functional prototypes to test design and functionality.
3. Testing
Laboratory Tests: Carry out tests under controlled conditions to evaluate the performance of the device.
Preclinical Evaluation: Test the device in animal models or in vitro to evaluate its safety and effectiveness.
4. Product validation
Final design: After the approval of the prototypes, we move on to the definitive design of the product, the preparation of the final technical data sheet, the analysis of the risks associated with the device and the creation of the definitive samples and equipment for product validation.
5. Industrialization and validation of the process
Sampling: Sampling is carried out on an industrial scale to validate the process
6. Regulatory Approval
Preparation of the Documentation and sending to the relevant regulatory authorities: Preparation of the technical file for its submission to the regulatory authorities for obtaining the CE and/or FDA marking or that relating to the country in question.
7. Production
Manufacturing Process Design: Development of a scalable and regulatory compliant manufacturing process
Mass Production: After approval by the relevant regulatory bodies and the customer, large-scale production of the device begins.
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