How confident are you that your medical device software processes could withstand a regulatory review?
IEC 62304 provides the framework for developing and maintaining medical device software, but successful implementation requires more than documentation. It requires a risk-based approach, clear traceability, and processes designed to support both quality and compliance.
Whether you're developing embedded software, Software as a Medical Device (SaMD), or AI-enabled healthcare solutions, understanding IEC 62304 is essential.
Our latest article highlights the key principles of medical device software process design, including lifecycle management, risk-based development, quality assurance, and the challenges posed by modern technologies such as AI and cloud services.
Read the full article and subscribe to our Medtech Compliance newsletter on LinkedIn.
Intreested in learning more?
Aurevia and Intertek Academy offer practical training on Medical Device Software Process Design based on IEC 62304, helping professionals understand software lifecycle requirements, risk-based development approaches, and real-world implementation of the standard. Learn more about this upcoming training.
In case you missed it
In the previous edition of our LinkedIn newsletter, we explored the ongoing IVDR transition, highlighting key regulatory deadlines, common compliance pitfalls, and practical considerations for IVD manufacturers navigating the changing regulatory landscape.
Read the article: The IVDR Transition Is Not Over: Key Deadlines and Common Pitfalls