QM-Services

  • Interim Management
  • Cross cultural – intercultural Management

 

  • Optimisation of Quality Assurance Processes
  • Inspection readiness – FDA, local authorities, customers, …

 

  • Medical device Management Review Report
  • IMPD – ctd formats
  • GMP services: applications, registrations
  • Internal audits
  • Supplier audits – e. g. Change of manufacturer
  • Third party audits
  • Site master files (smf)
  • Risk Analysis
  • Deviation Management
  • Complaint management