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. rer. medic. Mette Stoedter

 

Consultant

  • Medical Writing
  • Clinical Writing, e.g. Clinical Evaluation (MDR 2017/745), Biological Evaluation (ISO10993), PMS-/PMCF- Plan & Report (MDR 2017/745), Investigation Plans & Reports (ISO 14155)
  • Safety Writing e.g. Periodic Safety Update Report (PSUR as per MDR 2017/745), Summary Safety and Clinical Performance Report (SSCP as per MDR 2017/745).
  • Literature Review
  • Review of documents

Lisa Möller

 

Consultant

  • Creation of technical documentation according to MDR and IVDR e.g.: Biological Evaluation (ISO 10993, ISO 18562), Performance Evaluation (MDCG 2022-2), Risk Management Files (ISO 14971), PMS-/PMCF/PMPF- Plan & Report (MDR, IVDR), Test Plans & Reports (ISO 14155), SW documentation (IEC 62304)
  • Support in the transition from IVDD to IVDR
  • Support in planning and monitoring of analytical and clinical performance evaluation studies
  • Quality Management Representative
  • PRRC
  • Support for international approvals e.g.: FDA 510(k)
  • Creation and implementation of QM systems according to ISO 13485, MDR and IVDR

 

Consultants und Associates

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

nach ISO 14971

Call: +49 9123 1529250
Mail: info@be-on-quality.com

Office adress, Visitors adress, Büroanschrift:
be-on-Quality GmbH
Bahnhofstrasse 85
91233 Neunkirchen am Sand

Headquarter of  be-on-Quality GmbH
Lilienstrasse 33, 91244 Reichenschwand