Efficient Software Validation According to MDR

Critical functionalities like seamless batch traceability must be validated.

The Medical Device Regulation (MDR) imposes strict requirements on manufacturers of medical devices – especially regarding the validation of the software solutions used. For small and medium-sized enterprises, this often entails a significant organizational burden.

This is where the “Validation” module by majesty comes into play. It offers a well-thought-out, field-proven solution for ERP systems used in regulated environments.

The module provides an electronic function catalog that lists all Majesty functionalities in a structured way. Users can assess the criticality of each function – from "critical" to "non-critical" to "not used". This makes it easy to identify which functions require validation.

During software updates, the system automatically analyzes which changes are critical and require testing. Only these need to be retested and documented. The test execution can be recorded directly in the system and completed with a legally compliant release protocol.

In the medical technology industry, it is especially important to apply regular software updates to implement regulatory changes or integrate safety-relevant adjustments. The Majesty Validation Module is an effective tool for keeping revalidation efforts as low as possible. It helps save time and costs – revalidation typically affects less than 10% of all changes.

Thanks to its practical implementation and complete documentation, the Validation Module helps medical device manufacturers keep their ERP software MDR-compliant and audit-ready – efficiently, transparently, and audit-proof.