We create additional value with our business services

• Our IEC 80001 special services for medical IT
  
  
  • Planning of tailor-made „IEC 80001 entry scenarious“ (hospitals)
  • Optimizing the cost/benefit of IEC 80001. See how to efficiently reuse existing processes and ressources! (hospitals)
  • Coaching of the responsible managers on application and implementation of IEC 80001 (hospitals)
  
  
  • Impact studies: Is your business model still suitable when your customers request compliance according to IEC 80001? We evaluate your business risks and new business opportunities that arise when IEC 80001 is put into practice (manufacturers & vendors & IT suppliers)
  • IEC 80001 Readyness Review: Are you already prepared for a compulsory „Responsibility Agreement“ according to IEC 80001? We assess your level of readyness for IEC 80001 and help you to get your business processes right and ready (manufacturers & vendors & IT suppliers)
  
  
  
• Our other business services for medical IT
  
  
  • Development of international standards for the medical engineering domain
  • Training / lectures on various standards(families)
  • Consulting / Coaching on use / implementation of international standards
  • Medical device regulation/authorization: Consulting / coaching on implementation of the relevant standards, know-how transfer
  • Representating the position of MD manufactureres and MD users in international technical committies
  • Project management in development of medical IT
  • Project management in implementation of IT projects with healthcare institutions
  • Impact analysis: Identifying the impact of EU-guidelines and standards on business models and business processes
  • System interfaces: Development of technical guidelines to improve safety and efficiency in usage of medical IT
  • Consulting / coaching on risk management according to IEC 80001 - for healthcare institutions and manufacturers
  • Consulting / coaching on risk management according to ISO 14971 - for manufacturers
  • operative risk management according to IEC 80001-1 - for healthcare institutions
  • operative risk management according to ISO 14971 - for manufacturers
  • Elaboration of expert opinions
  • Interim management
  • Analysis of data problems & solution concept & reporting
  
  
  
  
  
  
• Our business services for industrial IT
  
  
  • Koncepts and planning for multinational ERP systems
  • System interfaces: Development of technical guidelines to improve safety and efficiency in usage of industrial IT
  • Technical system interfaces: Development of special programs for converting data and for automatization of system processes
  • Koncepts and consulting on audit-proof archiving systems
  • Elaboration of expert opinions
  • Project management in implementation of industrial IT systems
  • Project management in industrial IT software development
  • Interim management
  • Analysis of data problems & solution concept & reporting