The path to market for Software as a Medical Device (SaMD) is one constantly shifting beneath your feet. Regulations keep evolving, guidance varies across jurisdictions, and staying compliant requires deeper and deeper levels of technical knowledge, time, and resources that many teams simply don’t have in-house. Whether it’s understanding Rule 11 of the MDR, classifying risk levels per IMDRF, or validating clinical performance, every step is critical. Missing any one of them could put your product and patients at risk.
Eurofins Medical Device Consulting is a trusted partner to SaMD manufacturers worldwide. We provide a global team of specialists with decades of combined experience navigating the regulatory and technical challenges of software-driven medical technologies. From early planning through to post-market monitoring, we can help you meet expectations, manage risks, and accelerate development.
With Eurofins Medical Device Consulting by your side, you will have the support of a global network of experts who understand both your SaMD challenges and the urgency behind them.
Our team of experts can help you interpret and apply IMDRF, FDA, and EU requirements, including MDR 2017/745 and IVDR 2017/746. We provide support in classifying SaMD products under Annex VIII and Rule 11, ensuring you meet the correct classification from the outset and avoid costly delays.
We can support compliance with ISO 13485:2016 and IEC 62304, helping you establish and maintain a QMS (Quality Management System) that meets international expectations for SaMD development. Our approach covers documentation, design controls, traceability, and risk management across the software lifecycle.
Eurofins Medical Device Consulting assists in assigning correct IMDRF risk categories (I–IV) and developing strategies to mitigate identified risks. For networked devices, we help implement cybersecurity frameworks aligned with FDA and MDCG guidance.
Our consultants stay up to date with evolving approaches for AI-based SaMD. We help ensure that your product’s adaptive algorithms remain interpretable, auditable, and ready for regulatory scrutiny.
We design and support studies to gather the clinical evidence required for performance and safety validation. Our teams also provide guidance on ensuring compliance with GDPR and HIPAA, including data security and patient privacy protocols.
