Medical devices truly have become a part of our everyday life. They cross our paths every day, be it as thermometers to measure body temperature, clinical care devices (e.g. infusion pumps), bandages, artificial joint implants or sterile products. Depending on its type classification, the demands on Hygiene Management in manufacturing of a medical device can be very high. The great diversity among medical devices requires certitude and experience in the interpretation and implementation of legal requirements.

Our services concerning Hygiene Management:

  • Gap analysis for identification of weak points and improvement measures in already existing hygiene concepts
  • Development of hygiene concepts for sterile and non-sterile production areas (zoning and lock concepts)
  • Preparation and optimization of hygiene plans
  • Preparation of check lists and work instructions for the hygiene subject
  • Conceptioning and administration of microbiological monitoring
  • Root cause analysis of hygiene-related problems such as OOS results in microbiological monitoring
  • Advising support in choosing cleaning agents and desinfectants for various applications
  • Conceptioning and optimization of personnel and material flows
  • Effective interactive and practical training of production staff and cleaning personnel in matters of hygiene