SOFTWAY MEDICAL

Softway Medical specializes in medical software solutions focused on patient monitoring and clinical decision support. Their portfolio includes systems for hemodynamic monitoring (like the HM LAP), cardiac output measurement (e.g., OX MPM), hemodynamic parameter calculations (e.g., PHMCalc), vascular imaging diagnostics (e.g., Venus Explorer), and clinical alert management systems (e.g., Alert Engine). These devices are designed to assist healthcare providers in real-time patient assessment and treatment decisions.

Softway Medical is based in France, which places its devices under the jurisdiction of the European Union’s medical device regulations. Since the company develops software-as-a-medical-device (SaMD) and connected health technologies, its products must comply with EU requirements, including classification under EU MDR (Medical Device Regulation) and mandatory listing in the eudamed registry. The French location ensures alignment with EU standards for safety, performance, and regulatory transparency.

All of Softway Medical’s devices are listed in the eudamed registry, the official EU database for medical devices. This registry is maintained by the European Commission to ensure transparency and traceability of devices authorized under EU medical device regulations. Listing in eudamed is mandatory for all Class I and Class IIa devices, including Softway Medical’s software-based solutions.

Softway Medical’s devices are classified as Class I and Class IIa under the EU Medical Device Regulation (MDR). Classification is determined by factors like intended use, risk level, and interaction with the patient. For example, software used for non-invasive monitoring (e.g., hemodynamic parameters) may fall into Class IIa due to its role in critical clinical decisions, while simpler diagnostic tools (e.g., vascular imaging software) might qualify as Class I. This classification influences the regulatory requirements, such as clinical evidence needed for authorization.