Overcoming Submission Challenges in Post-Market Surveillance & Lifecycle Management

Abstract

Post-market surveillance and lifecycle management are confronted with some major challenges, such as regulatory compliance, reliability of data, and submission inefficiencies. The literature emphasises the importance of digital solutions like artificial intelligence and automation in increasing surveillance accuracy and efficiency. This study employs an explanatory design based on secondary qualitative and quantitative data. Key findings highlight the growing uptake of AI-powered solutions, enhancing regulatory filings, risk identification, and real-time monitoring. Businesses need to invest in AI adoption, data governance, and regulatory flexibility to increase the efficacy of surveillance. Enhanced collaboration between regulatory authorities and industry partners is crucial for ensuring long-term safety and innovation in medical device management.