You develop software as part of a medical device or as a standalone medical device and want to secure conformity to existing standards? As a software development partner, PROSYSTEM AG provides the required components. Our quality management system is certified according to DIN EN ISO 13485 and we own a software development process that reflects the software-lifecycle of IEC 62304/IEC 82304. We consider the topics risk management, usability and clinical evaluation as well as verification and validation of software.
Because of our membership in the IEC 62A/ISO TC210/JWG3 and IEC 62A/ISO 215 JWG7, as well as many years of experience in developing and the approving of software, we are the ideal partner for manufacturers of medical devices.

For further details on the topic “software” or a nonbinding quotation, please contact us.