IEC-62304, ISO-13485
Software Compliance

The medical device software created by Critical Software Solutions is designed to meet all applicable international regulatory standards. We know the ins and outs of IEC 62304, which applies to the development and maintenance of both standalone and embedded medical device software. Our software also fulfills the requirements of ISO 13485, the quality management system specific to the medical devices industry. We navigate this complex regulatory maze so you can be confident that your project will get the regulatory green light when it’s ready to hit the market