Dossier management MedTech

The requirements and challenges in the medical technology field are becoming increasingly demanding. They also place higher and higher demands on the quality system, which in turn places ever higher demands on the handling of the documentation for products.

Advantum Dossier Management MedTech is an effective solution for creating, maintaining and archiving documentation for products throughout the entire process from idea and development phase to finished product. The system also helps keep track of product versions for a product and its documentation, as well as when a product version is discontinued. It is also possible under each product to manage documentation regarding risk management.

The use of Advantum Dossier management MedTech eliminates inefficient and time-consuming processes while the documentation is saved in a standardized structure with DHF (Design History File), DHR (Device History Record), DMR (Device Master Record) and Technical file.

Examples of functions in Advantum Dossier management MedTech:

• Create and manage products and product versions
• Classify product versions
• Structure documentation for product versions
• Risk assessment file and its documentation for products
• Create and manage documents
• Template management
• Version management
• Electronic signature
• Create and manage and sign with role
• Standardized processes
• Find information based on different perspectives and search functions
• Management of access rights via groups and roles
• Audit trail
• Prepared import for documents