Whether your product is a medical or diagnostic device, its classification, risk level, and the necessary clinical and validation studies are all directly related to the Intended Use you define. Furthermore, this serves as the primary reference point that legally binds you and establishes your responsibilities according to regulatory requirements.
Since the device's risk level and classification will vary depending on its intended use, influencing all subsequent processes and associated costs, we recommend that you define your intended use very clearly in collaboration with experts knowledgeable in medical/diagnostic device regulations. This strategic decision is crucial for aligning your approach with regulatory requirements and ensuring efficient resource allocation.
For Software as a Medical Device (SaMD), the necessary documents for software validation should be prepared by applying Software Development Life Cycle (SDLC) processes in accordance with IEC 62304.
Naturally, for software with a high risk level that could impact the patient/user, both the number and the content quality of the documents you prepare will increase accordingly.
