Development and Design: In this phase, medical devices are conceived, designed, and developed. Preliminary studies may be conducted in the laboratory to assess the device’s functionality and safety.

Feasibility Study: Before initiating a large-scale clinical investigation, a feasibility study is conducted to evaluate whether the device can be effectively tested on real patients.

Regulatory Approval: This process involves submitting complete documentation for review by Ethics Committees and regulatory bodies.

Clinical Study: This is the main phase of pre-market investigations. Clinical studies are conducted on patients to gather data on the device’s effectiveness and to identify any side effects or risks, evaluating conformity accordingly.

Data Submission: Once clinical studies are completed, data is submitted to regulatory authorities to obtain final approval for marketing the device.