Your personal guidance and professional expertise to
Medical Device and Health Care Compliance

Mona Lisa is a worldwide manufacturer of cupper Intra Uterine Devices.

For more than 10 years, Lieven has served Mona Lisa in quality aspects, helping make the QMS more smooth and ready for NB and client audits in several aspects like validation, risk management, internal and external auditing, etc. Lieven has helped to upgrade our class III Technical STED files with the current guidelines and establish the practical link with our quality management system. Great work!

While most large pharmaceutical and biotechnological companies have their own in-house teams to interpret, implement and follow up on the new GDP guidelines, many smaller companies are still working towards their GDP certification. Cogezaf was one of these companies. In a three-month period, Lieven tackled the existing QM system into a workable and practical living validated and qualified system with a multidisciplinary approach. He also provided us with the necessary training, so that we at Cogezaf could easily manage the GDP system ourselves.