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