Software as a Medical Device (SaMD) refers to software or mobile apps intended to treat, diagnose, cure, mitigate, or prevent disease. SaMD has key characteristics like fast feedback loops, improved health outcomes through data collection, and the ability to quickly solicit user feedback and drive innovation. The FDA designates four categories of SaMD based on their intended use and the significance of the information they provide for clinical management and treatment. Common applications of SaMD include screening, diagnosis, monitoring patients, and managing chronic conditions and diseases.

1. Software as a Medical
Device (SaMD)

2. What is Software as a Medical Device (SaMD)?
• According to the FDA, SaMD is a class of software that is designed to carry out
one or more medical functions.
• This includes software or mobile apps intended to treat, diagnose, cure,
mitigate, or prevent disease or other conditions.

4. Key Characteristics
SaMD’s defining characteristics include:
 Fast feedback loop can enable quicker product iterations,
 Improved health outcomes powered by data.
 Collect large amounts of data quickly,
 Easily solicit user feedback through its availability
 Shorten time to market, and drive faster innovation.
 Faster production and feedback to drive faster innovation.

5.  Better user understanding of a patient's current
medical condition,
FDA designates four separate categories for SaMD, each with its own
characteristics and unique requirements for clinical evaluation.
State of Healthcare
situation or condition
Significance of information provided by SaMD to
healthcare situation
Treat or
Diagnose
Drive clinical
management
Inform clinical
management
Critical IV III II
Serious III II I
Non Serious II I I
Understanding Categorization of Software Medical Devices

6. Applications of SaMD platforms
 Screening and diagnosis
 Monitoring and alerting
 Chronic condition and disease management
 Digital therapeutics

7. Johari Digital Healthcare as India’s Preferred Contract Manufacturer
Johari Digital Healthcare is a leading contract manufacturer of electronic medical
devices in India. We have 40+ years of experience with low volume simple
projects to high volume complex projects.
Our strict adherence to US FDA and ISO: 13485 and MDSAP guidelines makes us
trusted and worthy manufacturing partners in India.

8. To Get In Touch