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.

Lead Consultants

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

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

Principal Clinical Evaluation and Investigation
Consultant
  • IVD
  • Medical device software IEC62304/IEC82304
  • Medical electrical equipment IEC60601-x
  • Clinical evaluation according MDR 2017/745 and ISO14155
  • Design Dossiers and technical documentation

Raje Devanathan

Principal Asia
 
Consultant
  • Auditor ISO13485
  • FDA
  • Medical electrical equipment IEC60601-x
  • Clinical evaluation according to MDR 2017/745 and ISO14155
  • Design Dossiers and technical documentation

Consultants and Associates

Through our team of consultants and associates, we are able to handle larger projects or quickly handle higher volumes of work.