MedTech and Digital Healthcare guidance
Consulting for the development of medical devices, encompassing SaMD, SiMD, and connected devices—ensuring regulatory compliance, safety, security, and conformance to ISO 13485
MedTech Software & Digital Health Consulting
Software lifecycle consulting for SaMD, SiMD, and connected medical devices
Architecture, design, and development guidance with IEC 62304 (lifecycle) and ISO 14971(product risk management) frameworks
Cloud, data, and interoperability consulting Fast Healthcare Interoperability Resources(FHIR/HL7), DICOM, and IoMT
Software verification and validation, planning, and technical documentation
Guidance for medical software powered by AI/ML within regulatory frameworks - EU AI Act and EU Data Act