At Pyramid, we take pride in developing software in alignment with IEC 62304 standards, ensuring the highest level of quality and safety for medical devices. Each software solution we create has its own specific compliance statement tailored to its unique requirements. While we do not offer formal IEC 62304 certification, we are committed to supporting our clients by providing comprehensive documentation needed for regulatory purposes, such as risk assessments or FDA 510(k) submissions. This enables our partners to meet their regulatory obligations with confidence and ease.