Abstract
The volume of data analysis for medical device post-market surveillance (PMS) has increased dramatically in recent years. It is the more stringent and intricate regulatory criteria of the health authorities that are meant to improve the medical device safety review. As regulators scrutinize device safety more closely, proactive approaches to PMS processes are becoming crucial. To solve some of the issues brought on by this shifting regulatory landscape, new technologies have been investigated. This study envisages the technical features of blockchain technology (BCT) and its role in enhancing the PMS for medical devices. To address the aforementioned challenges, our model involves the establishment of a secure, permissioned blockchain for PMS data management, utilizing a proof-of-authority consensus mechanism. This blockchain framework will exclusively permit a carefully vetted and designated set of participants to validate transactions and record them in the PMS data ledger. The utilization of BCT holds the potential to introduce enhanced efficiency and provide several advantages to the various stakeholders involved in the PMS procedure, including its potential to support emerging regulatory efforts.