Are you developing software as part of a medical device or as a stand-alone medical device and want to ensure compliance with existing standards? As software development experts, we have a DIN EN ISO 13485 certified quality management system and a software development process that maps the software lifecycle in accordance with IEC 62304:2006+A1:2015 and IEC 82304-1:2016. We consider risk management, usability and clinical evaluation as well as the verification and validation of software. Through our cooperation in the IEC 62A/ISO TC210/JWG3 and IEC 62A/ISO 215 JWG7 and our years of experience in the development and licensing of software, we are the ideal solution for medical device manufacturers.
For more details about software development or for a non-binding offer please contact us.Take advantage of one of our seminars on software as a medical device or process validation.