Hello!
My name is Ronald Plock and I am your new
Interims-Manager / Service-Provider / Consultant / Freelancer
in:
- Projectmanagement
- Qualitymanagement
- ISO 9001, ISO 13485
- FDA QSR 21 CFR part 820
- GMP, GDP, Deviations, CAPA
- Regulatory Affairs
- Approval of Medical Equipment (CE + FDA)
- Approval of Combined Products (CE + FDA)
- Risk Management
- ISO 14971
- Requirement Engineering
- Requirement Concepts and Tracebility
- Verification & Validation
- Verification by German Medical Act, EU and FDA- requirements
- Validation by German Medical Act, EU and FDA- requirements
- Research & Development
- Development of Medical Equipment, Measurement Transducer and PC based Measurement-Places for the endcheck-control and Verification