Possibility of Managing Medical device Post-market Surveillance using Artificial Intelligence and Standardized Methodology
The activities related to medical device market can be divided into pre-market and post-market surveillance. Pre-market processes have been defined by Medical Device Directives since 1992. These directives define all aspects of medical device design, production, testing, approval and certification. Appropriate standards have been adopted to support these activities. The CE mark issued by European Notified Bodies confirms that the medical device complies with safety and performance standards related to its class and that is therefore safe for intended usage. Post-market surveillance is not as well defined, so the new Medical Device Regulation addresses the identified gap and emphasizes the importance of standardizing and harmonizing the system for surveillance of medical devices already in use. The MDRs require stakeholders to monitor the quality, performance and safety of a device throughout its life cycle and to take corrective or preventive action when necessary. In this paper, we discuss the possibility of using artificial intelligence on Big Data structures resulting from the comprehensive methodology of post-market surveillance.