- 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
| - Validation of medical devices
- Computerized system validation
- Assessor/Reviewer for technical documentation
- Design dossiers and technical documentation
- ISO9001:2015
- ISO13485:2016
- FDA 510(k)
| - 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
| - 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
| - Creation and implementation of quality management systems according to ISO 13485, ISO 9001 and 21 CFR 820
- Technical documentation according to (EU) 2017/745 („MDR“)
- Preparation of 510(k) submissions
- Risk Management according to ISO 14971
- Auditor
- Consulting concerning IEC 60601-1, IEC 62304 und IEC 62366
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