QUALITY & COMPLIANCE

Last Updated:  July 2025

At Aidoc®, exceptional quality is a core value that guides our development and operations.

Our Quality Management System governs all stages of our product lifecycle, and supports our mission of delivering high-performing, safe, and reliable medical software that healthcare professionals can trust.

• Certified to  MDSAP, Medical Device Single Audit Program
• Compliant with FDA’s Quality System Regulation (21 CFR Part 820)
• Certified to ISO 13485:2016, the global standard for medical device quality systems .
• Certified to EU 2017/745 (MDR) 

Compliant with ISO14971 (medical device risk management) and  IEC 62304 (medical device software development life cycle) 

Our Regulatory Affairs department ensures Aidoc’s products are registered and authorized for marketing in the regions where we operate. 

Aidoc’s triage and notification solutions are intended to assist healthcare professionals in identifying and prioritizing critical cases. They are not diagnostic software and are not intended to replace a clinician’s full interpretation of a medical image per standard of care. Clinical decisions should be taken only after evaluating the full original series in the PACS as well as other relevant information.

Aidoc’s Quantification solutions are intended to assist healthcare professionals by providing the measurements and quantifications of different radiological parameters.

The measurement results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of cases. Clinicians are responsible for viewing full images per the standard of care.

For information on Aidoc’s products, cleared solutions, safe and correct usage and indications for use, please refer to  Aidoc’s 510(k) premarket notifications on FDA’s website and to the respective device user guide.

For more information on quality, regulation or compliance, please contact: [email protected].