BAYOONET Inc. is a software house and, for the last 15 years, the producer of Qware® Riskmanager, the worldwide market leader in software solutions for risk management processes in accordance with ISO 14971, the creation of application of usability files (EN 62366) and of conformance reports (IEC 60601-1), as well as the creation of certificates of compliance with essential requirements (MDD 93/42/EEC and IVDD 98/79/EC) and the implementation of requirements engineering. The latest version 8.4.1 of Qware® Riskmanager is available!
Since 1994, we have administrated the interactive medical reference repository MEDiLEX – the digital loose-leaf binder for medicine and pharmacology. As editors, our in-house lawyers and consultants examine the current legal situation, note changes, and support our development team in keeping up with the latest status of regulations.
As one of the leading software development houses, BAYOONET is responsible for the successful development, installation, and support of individual software projects. Based on years of experience, we know the specific needs and requirements for flexibility and optimization of IT processes in detail. Through this added value, our customers gain a sustainable competitive advantage and we are proud that this is attested by our customers again and again.
BAYOOMED – We develop medical apps
BAYOOMED is the medical software division of BAYOONET Inc. Here we combine medical professional know-how with our software development expertise. We serve more than 400 clients from the pharmaceutical and medical technology sector, and we specialize in the development of medical (standalone) software and medical apps (iOS, Android, Windows 8) in accordance with IEC 62304, ISO 13485, ISO 14971 and EN 62366. We support our clients through all product lifecycle phases:
- Requirements engineering
- Risk management
- Software engineering
- Usability engineering
- Release in app stores
- CE-marking, FDA approval
- Post-market observation
We invite you to browse this site for further information about our service portfolio in the field of medical software development according to IEC 62304 (Medical Software and Medical Apps), as well as about our products Qware® Riskmanager and MEDiLEX. You can meet us in person at medical trade fairs and congresses where we exhibit and speak about our products, such as MEDICA, Medconf, the Medtech Pharma Congress, MEDTEC Stuttgart, the TÜV Süd Medical Device Forum, the Medical App Congress, as well as field-specific industry and chambers of commerce events, the US Chamber of Commerce, or at various universities.
We will gladly give you a free, non-binding, online presentation on our service portfolio or the performance of our products. Arrange an appointment today! We look forward to hearing from you.
MEET THE EXPERTS @ MEDICA 2016
Product development processes in medical technology necessitate the compliance with current regulatory requirements as well as an audit-safe documentation of these requirements. The guidelines of the US Food and Drug Administration (FDA) claim in 21 CFR part 820 a Design History File (DHF) where the design inputs and outputs as well as the design verification and validation throughout the life cycle must be documented in a transparent manner. In the Device Master Record (DMR) it must be described how a medical device needs to be produced. In the Device History Record (DHR) it must be described that the medical device was developed in accordance with the requirements of the DMR. According to ISO 14971 the risks must be analyzed, valued and documented throughout the life cycle. The essential requirements laid down in MDD 93/42/EWG must be fulfilled. The standard DIN EN 62366 requires manufacturers of medical equipment to perform a usability engineering process. Furthermore product specific requirements for medical electrical devices e.g. IEC EN 60601-1-6 must be implemented.
Qware® Riskmanager, the world’s leading software solution for creating technical documentation, avaMedbase, the industry extension of the Product LifecycleManagement (PLM) solution Siemens Teamcenter and the high-quality consulting services for regulatory compliance and regulatory affairs from IQC, will assist you during the generation of audit-safe documents for your medical devices with a minimum of work. Use your MEDICA visit: meet us in person and get into contact with our experts at our joint booth in Hall 15/ Booth A13. Click here to login...