QUALITY MANAGEMENT

A QM System should not only meet regulatory requirements. A good QMS should be a valuable management tool, with which you can optimally exploit your company's potential for improvement. This saves time and money.

Our Service

  • Selection of Notified Body
  • Setup, maintenance and review of your QM System
  • QM Manual, SOPs and work instructions
  • Process analysis, visualization and optimization
  • Risk management and CAPA
  • Audits and system analysis—internal and for suppliers

Production/Hygiene

  • Hygiene requirements
  • Production in cleanrooms
  • Validation of sterilization processes
  • Management of test equipment
  • Process validation
  • Refurbishing of medical devices
  • Package validation
We implement and improve Quality Management Systems according to:
  • ISO 9001
  • EN ISO 13485
  • CAN/CAS 13485
  • ISO 15378 (GMP & ISO 9001)
  • US-QSR (21CFR 820) cGMP