Software Requirements Specification Medical Device. It contains entries compliant with IEC 62304 IEC 62366 and ISO 14971. In order to get into the market the medical device needs to pass through certain regulatory compliances subject to both regional and international standards.
In order to get into the market the medical device needs to pass through certain regulatory compliances subject to both regional and international standards. Compile a FDA- and IEC 62304 compliant software requirements specification Easily prepare your medical device software documentation for FDA submissions and CE approvals. Definitions Specifications A specification is defined as a document that states requirements There are many different kinds of written specifications eg system requirements.
Specification creation and approval We transform your requirements into a detailed specification and await your approval before proceeding.
A company may decide what a device will do and then attempt to market that device. A doctor may have a device that does much of what he wants but needs additional features. We discuss your medical device software concept with you help you elaborate it and assist with prioritizing requirements. Different specification techniques are used in order to specify the requirements more precisely for different audiences.