Every medical device needs product documentation. The preparation of the design history file (DHF) or process documents is an essential part of the product value. Our passion is structured documentation that creates an added value for our customers along the product life cycle.
Drug / Device Combination
Definition and realization of a design and document control framework for a pharmaceutical company entering the medical device development.
Cleaning, Disinfection, Sterilisation
Validation and project management for a new reprocessing procedure for a fluid management system. Collaboration with external microbiological laboratories. CAPA handling and process validation.
Restructuring of design history files (DHF) including regulatory gap analysis. Planning and monitoring of development activities for anesthesia machines.