Software as Medical Device

Software as a Medical Device (“SaMD”) is software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. This includes software applications intended for use in the treatment, diagnosis, mitigation and prevention of diseases. SaMD may be used in combination with, or interface with, other medical devices, as well as general purpose software.

SaMD requires special considerations in documentation, engagement with Regulatory Authorities, premarket submission and QMS adaptation. Our team of experts can help you with specific knowledge and experience on Software Devices.

Our experts also support special considerations for Software in a Medical Device (SiMD) - those software systems integral to overall medical device function, though not stand-alone medical devices.

Software as Medical Device

Our experts will  guide you through the entire process, ensuring compliance with IEC 62304, ISO 14971, and global regulations like FDA, EU MDR, and IMDRF SaMD guidance. Our experts help you:

• Plan and Implement SDLC - Define requirements, architecture, and risk controls. Establish traceability and maintain compliance throughout development.
• Prepare Technical Documentation - From risk management files to software safety reports, we create complete Technical Files and Design Dossiers ready for regulatory review.
• Navigate Regulatory Submissions - Whether it’s FDA 510(k), De Novo, or CE marking, we ensure your documentation meets expectations and supports a smooth approval process.
• Adapt Your QMS - Integrate software-specific processes into your Quality Management System for long-term compliance and audit readiness.