Are you ready for FDA - is a single self-assessment consists of multiple questions covering the complete ISO 13485. - https://www.camensys.com/fda-readiness-assessment
In late 2017 FDA released a new guidance for medical device software and called it Software as Medical Device. They outsourced the development of various guideline to IMDRF. In this article we shall lay out various standards and guidelines as they apply to both Medical Device Software and SaMD. For More - https://www.camensys.com/medical-device-development-services
Camensys is a Technology Consulting, Software Development and Digital Marketing company located in San Francisco Bay Area helping companies in the areas of Artificial Intelligence, IoT, Digital Transformation for medical devices and industrial products. - https://www.camensys.com/paper-medical-device-software-samd