The service range of LitOS Consulting in the medical technology sector covers the following:

  • assistance in defining and formulating processes
  • creation of templates for the trace of evidence and documentation of the design verification and process validation according to the FDA guidelines, as well as adherence to the standardized V-Model
  • examination of the product documentation regarding the conformity with the norms, standards and guidelines to be applied (European Union guidelines, GMP, GAMP, etc.)
  • development of improvement measures in the entire product life cycle applying the SixSigma method
  • implementation of PIM and PDM/PLM solutions as well as configuration and change-management solutions
  • Training & Coaching of staff and business partners