Quality Management Systems

Quality Systems for Pharmaceutical, Biotechnology and Medical Device Industry

Our team members have established, improved and deployed Quality Management Systems in small-. mid-, and large-sizes companies including  corporate level Quality Systems of multi national companies. They are experienced in managing and driving proactively Quality Systems and quality organizations. We support your teams in communicating with national and international authorities and Notified Bodies.


Quality System Improvements and Support

Implementation of Quality Management Systems

Re-design of Quality Management System

Multi-Site Integration and harmonization with global / corporate Quality Systems

  • Establish Quality Oversight
  • Quality Key Performance Indicators

Quality Management Systems



Implementation of core processes:

  • Management Review – Quality Oversight
  • Quality System Audits, self inspections
  • Supplier Audit ; Supplier Management
  • Documentation Control, Changes
  • Nonconformance, Deviation, OOS, CAPA,
  • Incident / Vigilance Reporting
  • Recall Management
  • Field Alert / Field Safety Notice
  • Risk Management

Laws, Regulations & Standards:

  • USA Code of Federal Regulations
    • 21 CFR Part 210/211 (cGMP)
    • 21 CFR Part 820 (cGMP)
    • 21 CFR Part 11
  • European Good Manufacturing Practice (EU GMP)
  • Good Distribution Practice (GDP)
  • GxP
  • European Medical Device Regulations
    • Directive 93/42 EEC medical devices
    • Directive 98/79 EEC in vitro diagnotics medical devices
    • Directive 90/385 EEC active implantable medical devices
    • MDR 2017/745 Medical Device Regulation
    • IVDR 2017/746 In-vitro Diagnostic Regulation



  • Quality System Standards and Guidlines
    • ISO 13485
    • ISO 9001
    • ICH Q10 Pharmaceutical Quality Systems
    • Medical Device Single Audit Program
  • Risk Management
    • ISO 14971
    • ICH Q9
  • Human and Animal Tissue Regualtions
  • Cosmetic Regulations
  • Sterilization of Healthcare Products
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