Stefan Bolleininger

Focus of Consultancy:

Approval & Regulatory Affairs

• Medical Device Law MDR and IVDR
• CE Marking and Certification
• FDA Submission and Approvals
• ISO13485 Quality Management
• International approvals

Stefan Bolleininger is the founder of be-on-Quality GmbH and an independent consultant for risk management, quality management, regulatory affairs and development processes. His main area of expertise is the quality management support of development projects of medical device manufacturers during CE approval or FDA approval as well as their support through audits, assessments and inspections. In the field of “Risk Management and Usability for Medical Devices and Medical Networks” he holds a lectureship at the TH Nuremberg and is involved in the association “International Certified Professional for Medical Software (ICPMSB.e.V.)” as well as in the VDI expert committee “Quality Assurance for Software in Medical Technology.

Get in contact via e-mail: info@be-on-quality.com
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