Our main field of operation is the medical device and biotechnology industry area. This includes start-up, mid-size companies as well as multinationals.
For medical device manufacturers we work as consultant and/or fulfill the function of the Quality and/or Regulatory Affairs Manager, Project Manager of the Design and Development process or are Expert Member of the Design and Development team (D&D) project team. We fulfill similar roles at suppliers of e.g. raw material or device component suppliers, contract manufacturers or service providers.
Notified Bodies contract us as external reviewer of technical dossier parts (e.g. biological safety) or as external QMS auditor.