Building and launching a SaMD solution: A blueprint to navigate complex nuances

While building a residential home is no easy task, constructing even a basic hospital is far more complex.

Building a software-as-a-medical-device product (SaMD) requires specialized and extensive planning to achieve regulatory approvals, clinical rigor and market acceptance. The foundations that all SaMD efforts are built on includes a quality management system (QMS) and software development life cycle (SDLC) that are both SaMD-oriented. Some companies have taken years to lay these foundations. Others have leveraged SaMD manufacturers or specialized QMS and SDLC accelerators.

Relying on a single architect and your trusted general contractor team for a personal residence might suffice. But it takes a specialized team of resources to get a hospital properly designed, built and ready for patients and staff. This infographic describes the steps to building and launching your SaMD solution and how a specialized SaMD manufacturer can help you along the way.