Ultimate Guide to Software as a Medical Device

What is SaMD?

Fertility apps: Natural Cycles

Apps that can calculate medicine dosage depending on the patient’s current condition (e.g. diabetes control - eGlycemic Management System®)

Apps for image viewing (e.g. MRI, X-Ray, etc.): CardioFlux, AIR™ Recon DL

Software that runs MRI or X-ray machines

A mobile app that reads continuous data from a wearable (e.g. EKG monitor, blood glucose monitor, etc.)

A mobile app for patient-clinician communication

Software that encrypts data that is transmitted from a medical device

Software used for the maintenance of a hardware medical device

SaMD: definition and differences between software types

How does SaMD work?

SaMD categorization

Class A: No injury or damage to health is possible

Class B: Non-serious injury is possible

Class C: Death or serious injury is possible

SaMD: market size and perspectives

The difference between Software as a Medical Device and Medical Device Software

Medical Device Software and Digital Therapeutics

SaMD: What you need to know in 2023

EU (Germany, Switzerland, Austria) and US Regulatory Considerations

Wrap up