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Standards Compliance
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
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.
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