IntegriMed AB is a Sweden-based consultancy providing regulatory and quality support for Software as a Medical Device (SaMD) and other medical software. We support medical device manufacturers with software lifecycle processes, risk management and quality management activities throughout product development and maintenance. Our expertise includes IEC 62304, ISO 14971, ISO 13485, EU MDR and related regulatory requirements. Engagements range from focused assessments with a clearly defined scope, timeline and deliverables to ongoing regulatory and quality support tailored to the manufacturer’s needs. IntegriMed AB operates fully online and works with medical software companies regardless of location.