SaMD Medical Device Software
Special application consulting services unlocking MDR compliance for Software as a Medical Device
Our SaMD Medical Software services
All software products with an intended medical purpose are defined as a medical device under the EU MDR. Our team of medical professionals are experts at applying the Medical Device Regulation to the unique situation of SaMD.
Dedicated MDR software service
MDR compliance services developed specifically for medical software.
Comprehensive CE-marking support
Our 360° regulatory assistance ensures your product is ready for CE-marking under the MDR.
Technical documentation & data analysis
Our experts write CERs, PMCF Plans and other technical documents for MDR compliance.
Real-time PMCF data collection
Our EDC system's API allows automated, real-time data collection directly from your application.
Our in-house medical experts have extensive experience developing tailored SaMD regulatory systems. Start by talking with us so we can fully understand your needs.