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