LogoAutomotive Agile PEP Europe|November 30 – December 01, 2020, Maritim proArte Berlin

Stefan Becher


Qware® Riskmanager is the worldwide market-leading software package for generating comprehensive risk management files (ISO 14971), conformity reports for medical electrical equipment (IEC 60601-1 3rd Edition) and essential requirements (MDD 93/42/EEC and IVDD 98/79/EC ) as well as usability engineering files (IEC 60601-1-6 and EN 62366) for medical devices and in vitro diagnostic medical devices.

For medical device manufacturers we develop software according to IEC 62304 and ISO 13485, we develop medical apps and standalone software (software as a medical device). We support the complete lifecycle and manage the CE marking and FDA approval according to 510(k) or 513(g).

Effective software engineering methods are our key to success The realization of sophisticated business solutions requires the use of effective software engineering methods, ie exact planning and execution. Over more than 15 years of software engineering, bayoonet has developed numerous best practice approaches that resulted in a timely and high-quality software development process. If possible and necessary, we use generative software techniques (MDD / MDA). In addition, we also use conventional (V-Modell / RUP) and agile (Scrum / Extreme Programming) methods of software development. From many years of experience as a successful application developer, we know the success factors and risks of both traditional and agile working methods from a large number of projects. So you can count on us to always use the right mix of promising methods and tools for your requirements.
  • What is the best practice architecture for a software that has to fulfill the MDR, DSGVO and the FDA guidance for cybersecurity? Is it effective to split the engineering?
  • What are the additional requirements for medical software and medical apps to fulfill the MDR? Is it still possible to outsource medical software to providers that are not certified by ISO 13485:2016?
  • What is the most efficient way to engineer and maintain a medical software that should be released in multiple regulated-markets (FDA, CE, CFDA,…)?
  • What are the decision criteria to decide if a medical software component should be engineered from scratch or based on an unvalidated SOUP component? Are there new aspects according to the MDR?
  • Should multiplatform apps for Android and iOS devices engineered native or with crossplattform tools like Xamarin? Are this general criteria or does it belong to the individual requirements of the app?
Do NOT follow this link or you will be banned from the site!