MDR equipment validation process discussed at Pharmapack

Invotec has developed a new process for equipment validation to support companies in the fulfilment of the European Medical Device Regulation (EU-MDR).

Coming into force on 26 May, EU-MDR will require medical device manufacturers to meet higher documentation requirements within a shorter reporting deadline—meaning many manufacturers are facing a significant increase in effort during the validation process. Invotec has developed a process that provides integration of equipment validation into the project process, aimed to ease the pressure of validation.

During the planning phase, Invotec works with the customer to create a customised project plan and define the necessary documentation to satisfy the EU-MDR. The following design phase builds on these definitions and works to minimise risks through controlled documentation of the development. Finally, in the testing phase, the functionality is verified and documentation for the performance of the equipment is provided.

The company is talking about its offering at Pharmapack up until 6 February.