Software Device 510K

What Makes SaMD Unique?

Functions without being embedded in a traditional medical device
Used for data analysis, diagnostics, treatment recommendations, and patient management
Common in areas like cardiology, radiology, oncology, and mental health
Global Regulatory Oversight
SaMD is tightly regulated to ensure patient safety and performance reliability, with different requirements depending on the region:
U.S. (FDA) – Subject to 510(k), De Novo, or PMA pathways based on risk
Europe (EU MDR) – Requires CE marking under the EU Medical Device Regulation
United Kingdom (MHRA) – Compliance under UK-specific regulatory frameworks
The classification and regulatory pathway depend on the intended use, risk level, and impact on patient outcomes.
Get Expert Regulatory Guidance
At RAPS, we specialize in guiding software developers and medical technology innovators through the entire regulatory process—from classification to compliance and submission. Whether you're launching a diagnostic AI tool or a clinical decision support platform, we help ensure your SaMD meets all global regulatory requirements.

Common Types of Software as a Medical Device (SaMD)
Software as a Medical Device (SaMD) covers a diverse spectrum of digital solutions designed to perform medical functions without being part of a physical device. These tools play a critical role in modern healthcare by improving diagnostic accuracy, streamlining workflows, and enhancing clinical decisions.
Here are some widely recognized categories of SaMD:
Clinical Decision Support Systems (CDSS)
Software that analyzes patient data and medical knowledge to assist healthcare providers in making informed clinical decisions—ranging from treatment recommendations to diagnosis alerts.
Electronic Prescription (e-Prescription) Systems
Applications that enable healthcare professionals to electronically generate, transmit, and manage prescriptions—improving accuracy and reducing medication errors.
Laboratory Information Systems (LIS)
Software that manages, tracks, and stores laboratory data including test orders, sample tracking, and results reporting—ensuring data integrity and compliance.
Radiology Information Systems (RIS)
Tools used to manage medical imagery and radiology workflows. These systems often integrate with PACS (Picture Archiving and Communication Systems) for image storage and retrieval.
Clinical Information Systems (CIS)
Comprehensive platforms designed to manage all aspects of patient care in hospitals and clinics—from patient records to diagnostic results and care plans.
Each type of SaMD must meet specific regulatory requirements depending on its intended use, risk classification, and region of operation. Whether standalone or integrated into a broader ecosystem, these software tools are reshaping how healthcare is delivered and managed globally.

SaMD Consultants & FDA Compliance
Navigating the regulatory landscape for Software as a Medical Device (SaMD) can be complex, especially when seeking FDA 510(k) clearance. This is where experienced SaMD consultants come in. They play a pivotal role in guiding software developers through every stage of the regulatory journey to ensure compliance and accelerate market access.
Strategic Regulatory Planning
SaMD consultants evaluate whether your software qualifies as a medical device and assess its eligibility for the 510(k) pathway. They help determine if your product is substantially equivalent to an existing FDA-cleared predicate device by analyzing intended use, technological features, and performance benchmarks.
510(k) Documentation & Submission
Whether you're pursuing a Traditional or Abbreviated 510(k) route, consultants support the preparation of a complete submission file, including:
Device description and intended use
Software architecture and documentation
Version control and software lifecycle information
Performance and validation testing data
Risk analysis and usability engineering
Labelling, instructions for use, and promotional materials
They ensure your submission adheres to the FDA’s content and formatting requirements, reducing the risk of RTA (Refuse to Accept) rejections.
Risk Management Support
SaMD consultants help establish a compliant risk management framework in line with standards like ISO 14971. This includes:
Hazard identification and risk analysis
Implementation of control measures
Residual risk evaluation and documentation
A robust risk management file is essential for gaining FDA clearance and maintaining patient safety.
Gap Analysis & Remediation
Consultants perform thorough reviews of your existing documentation and processes to identify any gaps. They provide practical remediation strategies to ensure compliance with applicable FDA guidance documents, recognized consensus standards, and software validation requirements.
FDA Communication & Representation
As your regulatory liaison or official US Agent, SaMD consultants manage communication with the FDA throughout the review process. This includes responding to feedback, handling requests for additional information, and updating submission files as necessary.
The Result:
With the right consultant, small and mid-sized software developers can confidently navigate FDA requirements, minimize delays, and bring safe, effective SaMD products to market faster and with less regulatory risk.
Looking to streamline your SaMD 510(k) clearance? RAPS is here to help you every step of the way.

Software as a Medical Device (SaMD)

What Makes SaMD Unique?

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