The portfolio includes the development of medical apps, client server systems, Web applications, and Office Automation, software development in accordance with IEC 62304. Metecon GmbH Metecon GmbH supports the manufacturer of medical devices in inspection and testing, documentation and approval of medical devices. Founded in 1999 by Alexander Fink and Ulrike Kamecke, Mannheim is currently 17 staff specialists from various fields for hardware and software development, study and test planning as well as documentation and approval all. cooperation bayoonet AG and Metecon GmbH is a close collaboration between the bayoonet AG and Metecon GmbH since December 2012: supports as a Gold partner Metecon GmbH the bayoonet AG in sales and consulting of Qware Riskmanager, the world’s leading software product for establishing the risk management file according to DIN EN ISO 14971. of Qware Riskmanager after European and American legislation for medical devices, in vitro diagnostic medical devices and active implantable medical devices according a risk management according to the international standard ISO 14971 called.
Increasingly, this requirement incorporated in more relevant product for medical devices and process standards for risk management. Thus, it comes quickly to numerous cross-references between the various documents that must be kept continuously up-to-date. Of Qware Riskmanager is the world’s leading software product for medical devices for the creation of risk management file according to DIN EN ISO 14971, use fitness file according to DIN EN 62366 and conformity report according to IEC 60601-1, 3rd Edition. In a clearly structured environment all relevant information is recorded, Central and revision-proof on a SQL Server stored and dynamically interconnected; the Of Qware Riskmanager accelerates the development and approval process..