Company Profile Medical Apps Development - Licensing of Medical Devices bayoonet AG is a software development company and, for the last 14 years, has been the manufacturer of Qware Riskmanager (http://www.risk-online.de), the global leading software solution for the risk management process in accordance with ISO 14971 , the creation of usability files (EN 62366) and the conformity report (IEC 60601-1), the verification of essential requirements (MDD 93/42/EWG & IVDD 98/79/EC) and the implementation of requirements engineering. Since 1994, we have been in charge of the interactive medical reference book MEDiLEX (http://www.medilex.de), the digital loose leaf system for the medical and pharmaceutical industries. As the publisher, our in-house lawyers and advisers check the effective law, compile changes and support our development team in being up-to-date in terms of regulations. As one of the leading software development companies, bayoonet is responsible for the successful development, commissioning and maintenance of customised software applications, which represent individual requirements and are handed over to our customers ready for use . Based on our many years of experience, we know the specific detailed needs and requirements to make IT processes flexible and optimised. As a result, we achieve an added value for our customers, with which they achieve a long-lasting competitive edge and we are proud that this is attested repeatedly by our customers. BAYOOMED - We develop medical apps BAYOOMED is the Medical Software Division of bayoonet AG. This is where our expert medical knowledge is combined with the expertise of our software development. We support more than 400 customers from the pharmaceutical and medical engineering sector and are specialised in the development of (stand-alone) medical software and medical apps (iPhone, iPad, Android & Windows 8) as per IEC 62304, ISO 13485, ISO 14971 and EN 62366. We support our customers in all phases of their product lifecycles: • Requirements engineering • Risk management • Software engineering • Usability engineering • Testing • Rollout • Publication in app stores • CE marking / FDA licensing • Market observation Our work follows a quality management system in accordance with ISO 9001 and ISO 13485. We warmly invite you to our stand in Hall 15 Stand A13 and will be happy to answer all your questions about our range of services in the field of medical software development in accordance with IEC 62304 (medical software and medical apps) and about our products, Qware® Riskmanager and MEDiLEX. You can also meet us in person as exhibitors and speakers at medical trade fairs and conferences such as Medconf, Medtech Pharma Congress, MEDTEC Stuttgart, the Medical Device Forum of the TÜV Süd, the Medical App Congress and at industry-specific events run by chambers of commerce and industry, the American Chamber of Commerce and various universities. We are happy to provide you with no-obligation details of our range of services and the performance of our products in a free online presentation. It’s best to arrange an appointment now. We look forward to meeting you.