Quality Management, Clinical Affairs & Documentation

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.

 

  • Establishment of Design Dossiers and Design History Files (DHF) according to 21 CFR 820
  • Quality management system implementation compliant with ISO 13485
  • Clinical evaluations with our external medical experts
  • Support of product approvals (CE marking and FDA)


Some examples:

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.

 

Anesthesia

Restructuring of design history files (DHF) including regulatory gap analysis. Planning and monitoring of development activities for anesthesia machines.