Quality Management / Regulatory Compliance

In the highly regulated environment (medical devices, pharmaceuticals, etc.), but also in all other industrial sectors, it is important to establish and maintain efficient and beneficial management systems. The system is designed to help you in your everyday life. Not to be a burden. And certainly not be created for the auditor. Let us help you with this!

  • Establishment and optimization of quality management systems according to ISO 9001, ISO 13485 or Pharmaceutical Quality Systems (GMP, ICH10) for manufacturers and suppliers/service providers
  • Implementation of MDR/IVDR/MDSAP requirements into existing QM systems
  • Risk management according to ISO 14971 / ICH Q9
  • Pharma GMP / GDP
  • Qualification / Validation / Computerized Systems Validation
  • Elaboration and implementation of Best Practices, tailor-made for your company