Medical device manufacturers have a new task to fulfill, Software Validation; which is emphasized with the last version of EN ISO 13485: 2016.
It is a daunting task for many companies not because it is new but it requires a specialization in software validation that is not usually found among employees.
The good news is, in addition to other production processes, we provide validation services for software as well.
Without hiring a team of costly employees for this specific task AdviQual and its partners could validate any computerized system that affects your product’s quality, such as;
- Embedded Software
- Software that works as a medical device (SaMD)
- Administrative Software
- Quality Management Software
- Automated Production Machines Software
- ERP Modules
- Design and Statistical Software
- Product Surveillance Software
- Building Management Software
- HVAC Management Software
- Data Warehouse
- Logistics etc.