Software as a Medical Device

Quality Management System Consulting Services


Standards Compliance

Achieve and maintain medical device certifications and compliance. SaMD-QMS can help you select a notified body or registrar and guide your organization through the process of achieving your ISO13485 or MDSAP certification .

ISO13485:2016 : Medical Devices

IEC 62304:2006 : Medical Device Software - Software lifecycle processes

IEC 62366-1:2015: Application of usability engineering to medical devices

Audit Preparation and Representation

Ensure your organization is prepared for audits from the FDA, Notified Bodies and partners. SaMD-QMS can conduct your organization's yearly internal audits and represent you for external audits.