Software as a Medical Device

We are dedicated to empowering innovators in the development of Software as a Medical Device (SaMD). Leveraging our expertise in UX, data analytics, AI, and engineering, we help our partners create SaMD solutions that deliver precise, personalized medical interventions.


Guardian AI-powered remote patient monitoring for the operating room

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What is Software as a Medical Device

Functionality and Purpose

SaMD is designed to perform critical medical functions such as diagnosing, monitoring, preventing, or treating diseases. It operates purely as software, capable of functioning in various settings without being integrated into physical medical hardware

Platform Independence and Deployment

SaMD can run independently on general computing platforms, including smartphones, tablets, and cloud servers. This flexibility allows for widespread deployment and accessibility, enabling updates and scalability to address the evolving needs of healthcare.

Regulatory Oversight and Compliance

Software as a Medical Device (SaMD) must adhere to strict regulations enforced by the Food and Drug Administration (FDA) to ensure safety, effectiveness, and quality. These regulations include pre-market evaluations and continuous post-market oversight. Compliance with these standards is essential for maintaining the integrity and trustworthiness of medical software applications, safeguarding patient health and ensuring adherence to healthcare standards.

Software as a Medical Device Use Cases

Diagnostic and Screening Applications

SaMDs that analyze data like medical images (e.g., X-rays, MRI scans), physiological signals (e.g., ECGs), or laboratory results to detect diseases or conditions.

Informative Applications

These SaMDs provide information derived from patient records or other data sources to support healthcare decision-making. They might calculate risk scores, suggest potential diagnoses, or predict disease progression.

Monitoring Applications

Software that monitors patient conditions and can provide alerts to healthcare providers. These SaMDs are particularly useful in managing chronic diseases, post-surgical recovery, and intensive care.

Therapeutic Applications:

SaMDs that support or provide interventions directly. This can include software that adjusts drug delivery in real-time (such as insulin delivery adjustments via a connected insulin pump) or software that provides specific therapeutic suggestions based on patient data.

AI-powered remote patient monitoring for the operating room

Mobile app enables clinicians to monitor patient vital signs from their smartphone – multiple patients, one screen.


Requirement for SaMD

Quality Management System (QMS)

Software Development Lifecycle (SDLC) Management

Risk Management

Clinical Evaluation


Data Integrity and Privacy

Usability and Human Factors


Software Validation and Verification

Regulatory and Compliance Documentation:

Quality Management System (QMS)

Implement a QMS that complies with standards such as ISO 13485. This system helps manage the lifecycle of SaMD, ensuring consistent design, development, implementation, and maintenance practices.

Software Development Lifecycle (SDLC) Management

Follow a structured SDLC process that includes planning, development, testing, deployment, and maintenance phases. Regulatory guidance such as IEC 62304 can be used as a framework for developing medical software.

Risk Management

Conduct thorough risk assessments throughout the lifecycle of the SaMD in accordance with ISO 14971. This involves identifying, analyzing, and mitigating risks related to software functionality and patient safety.

Clinical Evaluation

Perform clinical evaluations to validate the safety, performance, and medical purpose of the SaMD. This should be in line with the intended use and based on scientific evidence.


Ensure robust cybersecurity measures to protect patient data and SaMD functionality. This includes securing data transmission, storage, and access, as well as regular security testing and updates as outlined by the FDA’s guidance on cybersecurity for medical devices.

Data Integrity and Privacy

Comply with data protection laws and regulations such as HIPAA in the U.S. or GDPR in Europe. Ensure integrity and confidentiality of health data through encryption, access controls, and audit trails.

Usability and Human Factors

Apply usability engineering practices to design SaMD that is easy and safe to use. This includes user interface design, user testing, and addressing potential use errors as per the principles outlined in IEC 62366.


Design SaMD to be interoperable with other medical devices and health IT systems, ensuring compatibility and seamless data exchange. This should follow relevant standards such as HL7, DICOM, and FHIR where applicable.

Software Validation and Verification

Systematically verify and validate software functions to ensure they meet all specified requirements, including performance benchmarks and regulatory standards.

Regulatory and Compliance Documentation:

Prepare and maintain thorough documentation for regulatory submissions and audits. This includes software specifications, test results, risk management files, clinical evaluation reports, and post-market surveillance data.

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How to get Started

HIPAA Compliant MVP

Launch a new service or product in as little as 8 weeks

VBC Technology Consulting

Consulting services for technology integration in Value-Based Care.

Strategic Assessment

An evaluation to guide critical business strategies and decisions.

HIPAA Compliance & PHI

HIPAA compliance is crucial for ensuring the security and privacy of Protected Health Information (PHI). At Digital Scientists, our extensive experience with PHI underscores our commitment to developing custom solutions that adhere to stringent data protection standards. This expertise not only helps prevent data breaches but also positions us as a trustworthy partner in the healthcare sector, adept at navigating complex regulations and maintaining the confidentiality and integrity of sensitive information.


What expertise does Digital Scientists offer in SaMD development?

Digital Scientists has a specialized team with extensive experience in developing medical software solutions. Our expertise spans from designing intuitive user interfaces and ensuring top-tier data security to integrating SaMDs with existing healthcare systems to advance diagnostic, monitoring, and therapeutic functionalities.


How can SaMD enhance clinical decision-making?

Our SaMD solutions improve clinical decision-making by providing healthcare professionals with advanced tools for diagnostics, disease monitoring, and patient management. These devices utilize real-time data processing and machine learning algorithms to deliver accurate, actionable insights, enabling more precise and personalized patient care.


What types of SaMD does Digital Scientists develop?

We develop a variety of SaMD solutions, including diagnostic software, monitoring systems that track patient health metrics, and therapeutic applications that can control or suggest adjustments to medication and therapies based on patient data. Each SaMD is custom-developed to align with the specific clinical needs and regulatory requirements pertinent to healthcare providers.


Can Digital Scientists integrate SaMD with existing healthcare ecosystems?

Yes, we excel in integrating SaMD with existing healthcare ecosystems, such as electronic health records (EHRs) and other clinical management systems. Our integration ensures that the SaMD operates seamlessly within the broader healthcare infrastructure, enhancing both usability and clinical value.


What is the process for developing a custom SaMD with Digital Scientists?

Our process for developing a custom SaMD includes initial consultations to capture specific clinical needs, designing the software architecture, developing and testing the software for both functionality and compliance, integrating the system within existing healthcare infrastructures, and providing ongoing support to ensure long-term success and compliance.


How does Digital Scientists ensure the security and compliance of its SaMD products?

We adhere to stringent regulatory standards such as those set by the FDA for SaMD. Our security protocols include robust encryption, secure data handling and storage, and strict access controls, ensuring that all SaMD solutions meet the highest standards of data privacy and patient safety.


What kind of support does Digital Scientists provide after deploying an SaMD?

Post-deployment, we offer extensive support services including technical assistance, regular updates to maintain compliance with changing regulations, performance monitoring, and user training to ensure that the SaMD continues to perform optimally in its clinical setting.


How do your SaMD solutions improve patient outcomes?

Our SaMD solutions contribute to improved patient outcomes by enabling enhanced disease detection, continuous health monitoring, and personalized therapeutic interventions. These technologies aid in earlier and more accurate diagnosis, ongoing health status tracking, and timely medical interventions, which collectively lead to better healthcare results.


What data is essential for building effective SaMD?

Effective SaMD development relies on diverse and accurate data sets, including medical imaging, physiological data, patient history, and real-time health monitoring data. Our development processes ensure that this data is utilized effectively and securely to drive the functionality of the SaMD.


How long does it typically take to develop and implement a custom SaMD solution?

The timeline for developing and implementing a custom SaMD varies based on the device’s complexity and the specific regulatory path required. Generally, projects can span from a few months to several years, covering phases from concept and design, through development and regulatory approval, to deployment and post-market surveillance.