Logo: Dox | Technical Documentation for Healthcare Products

QM documents

Our services are, for example:

  • Development documentation for medical
    devices according to DIN EN ISO 13485 and to 21 CFR Part 820
    (Subpart C)
  • GMP (Good Manufacturing Practice)- and GLP (Good Laboratory Practice) compliant documentation, e.g. qualification documents (IQ, OQ, PQ),
    SOPs (Standard Operating Procedures) and working instructions