Arvind Sharma
Independent Researcher
Punjab, India
Abstract
Post-market surveillance (PMS) plays a pivotal role in ensuring the continued safety and performance of dental devices after regulatory approval and market entry. Traditional PMS mechanisms often suffer from delayed reporting, fragmented data sources, and lack of real-time insights. The integration of Clinical Data Management Systems (CDMS) into dental device trials offers a transformative approach to enhancing PMS capabilities. This manuscript explores the effectiveness of CDMS in consolidating clinical data, automating adverse event detection, and improving regulatory reporting efficiency in dental device surveillance. Through a comprehensive literature review and methodological framework, this study examines how integrated systems support longitudinal monitoring and cross-center data harmonization, ultimately driving evidence-based risk assessment and proactive safety interventions. The results highlight improved traceability, reduced manual errors, and faster post-market feedback cycles when leveraging CDMS-driven PMS strategies. The manuscript concludes with policy and practice recommendations aimed at regulators, manufacturers, and clinical researchers in the dental field.
Keywords
Post-market surveillance, Clinical Data Management Systems, dental devices, regulatory compliance, clinical trials, adverse event reporting, safety monitoring
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