About us

We are a dynamic team of experts for your device approval and quality matters

Teaming together or in workshops and trainings we ensure the quality of your products and processes. Within the business we are driven to get a bonding line with our customer and drive a lean and successful approach. In our core competences we are adaptable to your need and can work with and for you in a direct cooperation or in project orientated setup.

Dr.-Ing. Stefanie Spallek

Consultant

  • Validation of medical devices
  • Computerized system validation
  • Assessor/Reviewer for technical documentation
  • Design dossiers and technical documentation
  • ISO9001:2015 & ISO13485:2016
  • FDA 510(k)
 

Dr. Cesare Magri

Consultant
  • IVD
  • Medical device software IEC62304/IEC82304
  • Medical electrical equipment IEC60601-x
  • Clinical evaluation according to MEDDEV 2.7.1 rev.4 and ISO14155
  • Design Dossiers und Technische Dokumentation

Stefan Bolleininger

Owner, CEO, Consultant

  • Multiple years of experience in quality management and regulatory affairs
  • Member at VDI comitee of experts „Software quality of medical devices“
  • Board member of the guidance „Best practice for medical device software development“
  • Trainer for Enterprise Architect
  • Author of the TPI Next(R) „Guidance for medical“
  • Adjunct professor at Nuremberg Institute of Technology „Usability and risk management for medical device and medical device data systems“
  • Qualitymangement Responsible
  • Auditor
  • CAPA & Change Management
  • Certified Professional for Medical Software