I like to translate processes for you,
I am proficient at it!
Hands on!
From the first step
right in the middle, for your audit!
Information security - quality management - medical technology
-  Information Security - ISO 27001Audit of information security management systems 
-  ISMS implementation and coachingHaving trouble getting started? 
-  Risk management for ISMS - ISO 27005Risk management in the context of information security (ISO 27001 – ISMS) 
-  Awareness training for employeesPositive Reinforced Behavior Patterns! 
-  Awareness training for ISMS professionalsAnatomy of a Cyber Attack 
-  Introduction of a digital certification solutionWould you like to secure your IT infrastructure quickly and find any gaps in the system? With DAISY you can start directly to record your current structure and check it against the existing requirements of existing IT security standards. Reduce cyber risks, step by step! 
-  Introduction to the Miter Attack FrameworkThe Miter Attack Framework is the ultimate framework, it is the knowledge management of those in the spirit of "Sherlock Holmes. 
-  Quality management - generic ISO 9001Process optimization, process streamlining? 
-  Coaching on QMS and process optimizationWithin the framework of individual workshops and coaching sessions, we address individual needs and questions. 
-  Risk management in general - ISO 31000Definition or optimization of the process. 
-  Company successor wanted? Plan ahead!Do you want to sell or hand over your company? 
-  AZAV employment promotion and certificationYou need support for your processes and documentation for certification according to the AZAV (Accreditation and Licensing Ordinance for Employment Promotion) 
-  Introduction of a digital certification solutionThe cross-industry IMS solution BASE is based on DIN EN ISO 9001 as a maturity management system and can quickly and easily digitize existing quality management systems in full. With Base, the costs of managing the QMS can be reduced while at the same time increasing process reliability. 
-  Dokumentation - Good Documentation Practiceprocess documentation 
-  IQ, OQ, PQInstallation qualifications Operational qualifications Process qualifications 
-  Quality Management - ISO 13485Process optimization, process streamlining? 
-  Requirements engineering, technical documentationHow do we define requirements? 
-  Risk management for medical technology - ISO 14971Risk management is the one process that affects almost all other processes in your QMS! 
-  Device Qualification / VerificationImplementation, concept, planning, technical documentation, measuring equipment capability analysis, verification, metrology, incoming goods inspections, test protocols, test reports, evidence and records, according to Good Documentation Practices (GDP) and compliant with ISO 13485, MDR, IEC 60601-ff... 
-  EU Medical Device Regulation MDR 2017/745The new EU rules for distributors of medical devices. 
-  Introduction of a digital certification solutionIf you want to bring a medical device to the European market, MIDAS is the right solution for you. You have a direct overview of all quality management system requirements relevant to you. 
-  CSV you need to carry outCSV: Computer Software Validations. 
Yours, Konstantin Ziouras (Dipl.Ing. FH)
The strenght is to be found in serenity!

 
  
 

