Software as a Medical Device (SaMD) refers to standalone software designed to carry out medical functions, such as diagnosis, monitoring, or treatment recommendations. Unlike embedded software, SaMD operates independently from hardware devices and therefore requires its own regulatory recognition and compliance.
Our service helps companies define whether their product qualifies as SaMD, clarify classification under FDA, EU MDR, or IMDRF frameworks, and prepare the necessary documentation. This ensures a faster and smoother path to market entry while reducing compliance risks.
Validation of medical software is essential to prove that the product is safe, reliable, and effective. It is not enough to demonstrate correct coding; validation must confirm that the software meets user needs, intended use, and regulatory standards such as IEC 62304, ISO 13485, and FDA guidance.
We support clients in building and executing validation strategies: from risk-based testing and verification plans to full documentation sets that satisfy regulatory expectations. This allows manufacturers to reduce audit findings, speed up certification, and ensure patient safety.
Clinical evaluation for SaMD ensures that software delivers a proven clinical benefit. Regulators expect documented evidence, ranging from systematic literature reviews to real-world performance data or clinical trials, depending on the risk classification and novelty of the product.
Our team guides clients through the clinical evaluation process by preparing evaluation plans, gathering and analyzing evidence, and integrating findings into the Clinical Evaluation Report (CER). This provides a strong foundation for regulatory approval and builds trust with healthcare professionals and patients.
Certification is the final step that opens market access. Whether aiming for CE marking in the EU, FDA clearance in the US, or registration with MHRA or TGA, every SaMD must undergo conformity assessment, risk classification, and documentation review.
We help companies navigate this process with services including gap analysis, submission readiness review, and strategic communication with regulatory authorities. Our expertise ensures that documentation is consistent, compliant, and audit-ready, allowing faster approval and fewer costly delays.
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