Validation causes more headaches for medical device manufacturers than almost any other stage of the production process. For companies certified to ISO 13485, validation is always a costly and time-consuming undertaking—regardless of whether a new process is being set up or an existing process is being transferred. To add to the challenges, manufacturers are confronted with new and stricter regulatory requirements, such as the European Medical Device Regulation, which comes into force this year.
These regulations aim to guarantee product quality based on process quality—in other words, by ensuring that processes are controlled and stable. Consistent process analysis and end-to-end proof of the quality of every step in the process are therefore essential.