International standards
ResScan Essentials was developed in accordance with recognized international standards to ensure safety, quality and regulatory compliance. The following standards were referenced to create this software:
IEC 62304:2006/A1:2015—Medical device software—Software life cycle processes.
IEC 62366-1:2015/A1:2020—Medical devices—Application of usability engineering to medical devices.
IEC 82304-1:2016—Health Software—General requirements for product safety.
ISO 13485:2016—Medical devices—Quality management systems – Requirements for regulatory purposes.
ISO 14971:2019—Medical devices—Application of risk management to medical devices.
ISO 15223-1:2021—Medical devices—Symbols to be used with medical device labels, labeling and information to be supplied.