AI-Driven QMS Revolution for Medical Device Software

It’s hard to imagine an advanced medical device today without software at its core. Whether the software is integrated into the device (SiMD) or is the device itself (SaMD), it drives breakthrough innovations that improve patient care and boost operational efficiency. However, development of software for medical devices is a complex task, as it must comply with strict regulatory standards to ensure safety and effectiveness.?

Creating software for medical devices requires careful planning and a significant amount of documentation. This documentation is managed through a quality management system (QMS), which is a formal framework outlining the structure, processes, roles, and procedures needed for effective quality control. A QMS includes key policies, procedures, forms, and work instructions, along with records that provide evidence that the system is being followed. For medical device manufacturers, it is also essential that the QMS aligns with international standards to meet regulatory requirements in different markets. The result is a labor-intensive process that generates vast amounts of documentation.

Large language models (LLMs) have emerged as a transformative solution to manage exactly this type of challenge. They can process and generate large volumes of unstructured text quickly, offering the potential to reduce time that manual document creation takes and to enable real-time updates as global and regional regulations evolve.

Imagine a system where a chain of AI assistants works together seamlessly: one assistant monitors and references regulatory guidelines; another compares these guidelines to the specific needs of a device; a third uses examples of past QMS documents to create new ones; and yet another analyzes design requirements to propose a risk matrix. Additionally, different AI agents could be dedicated to different document types—such as the overall QMS, standard operating procedures, or software development plans—all working in concert to produce a fully compliant system.

Today, it can take weeks to create all the necessary documentation for a medical software project, with full QMS implementation ranging from three to nine months. This lengthy process calls out for innovation. In life sciences, an LLM-powered creation of compliant content has already been demonstrated. For instance, Globant developed an AI agentic solution that reduced the time required to produce compliant marketing copy for the pharmaceutical industry by 80%. This success suggests that a similar strategy could greatly accelerate the creation of a compliant QMS for medical device software.

Admittedly, integrating LLMs into QMS development is not without challenges. Accurately interpreting complex regulations and ensuring the precision of generated documents remain significant concerns. Although advances in LLM technology have improved performance, human oversight will still be essential to guarantee quality and compliance. Nonetheless, the potential benefits are substantial, and the time to begin piloting this innovative approach is now.