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bayoonet AG – FDA & CE compliant medical apps & software


bayoonet AG is a software & IT-service provider with expert knowledge in large scale enterprise environments.

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The increasing popularity of smartphones and tablets has boosted the development of mobile apps for almost every part of our lives, including applications for health management. The US Food and Drug Administration (FDA) intends to apply its regulatory oversight to those mobile apps that are medical devices and whose functionality could pose a risk to a patient’s safety if the mobile app were to not function as intended.


Therefore, the FDA has released guidance on what software could be considered a medical device, so app developers need to consult with the regulations to pass FDA audits and support the guidelines defined in IEC 62304. In addition, international standards for the risk management (ISO 14971) or the quality management system (ISO 13485) have to be fulfilled and a technical file has to be created to get a CE Mark for the European market or 510(k) FDA market clearance.

bayoonet AG is a software & IT-service provider that supports the whole software-lifecycle from consulting services, IT service management through development of innovative software solutions, rollout & installation, maintenance, operations into modernization.

BAYOOMED is the medicalsoftware division of bayoonet AG. We support more than 400 US & European 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). The providing of high-quality services is especially for this clientele, which is operating in a highly regulated and responsible environment, an indispensable value. We are proud that we succeeded to outperform this quality demands over the last 10 years. We are aware of our responsibility and continuously invest in improving our standards. We are familiar and able to work in a compliant way for the US and European market according to ISO 9001, ISO 13485 and FDA Title 21 CFR Part 11.

Our product Qware® Riskmanager is the worldwide market-leading software solution for the risk analysis, the requirements engineering, the conformity reports for medical electrical equipment and usability engineering for medical devices and in vitro diagnostics. Qware® Riskmanager minimizes the effort to fulfill the regulatory requirements for CE labeling and FDA approval in the US and European market.

About The Company:

bayoonet AG is a software & IT-service provider with expert knowledge in large scale enterprise environments. We are familiar to work in a compliant way for the US and European market according to ISO 9001, ISO 13485 and FDA Title 21 CFR Part 11.

Contact:

Stefan Becher
CEO
bayoonet AG
Robert-Bosch-Str. 7
64293 Darmstadt
T +49 6151 870105-20
E stefan.becher(at)bayoo.net
W www.bayoo.net

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