Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
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SEARCH JOBSA robust and effective postmarket surveillance (PMS) system can reduce both costs and demands on resources, while increasing product safety and performance. The SmartSolve PMS module for MedTech will provide your organization with a workflow to manage, track and document all the steps from PMS planning through data collection, analysis and reporting.
In announcing recent amendments to its Medical Devices Regulations on requiring summary reports beginning in December 2021, Canada joins other regulators in raising the importance of post-market surveillance (PMS) in its oversight of medical devices. The US FDA under Section 522 of the Federal Food, Drug and Cosmetic Act is authorized to require manufacturers to conduct PMS for certain class II and class III medical devices and has just (May 26, 2021) issued draft revised guidance on PMS.
In Europe, the Medical Devices Directive (MDD) has always required device manufacturers to carry out PMS, and post-market clinical follow-up (PMCF) studies for some devices although many manufacturers simply relied on their vigilance and FSCA system to meet PMS requirements. The focus has widely been reactive, concentrating on collating and reporting adverse events, such as device malfunctions or patient injuries, to trigger product returns, modifications, exchanges and recalls as necessary. However, as medical device complexity increases, the approach to PMS will need to be more rigorous, leading to earlier detection of potential product failures in the field.
The EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR) confirm that PMS is much more than vigilance (ref. MDR Articles 83 – 86 and the detailed Annex III on Technical Documentation on Postmarket Surveillance.) At the heart of the requirements is a PMS plan based on proactive data gathering and analysis, with close links and inter-relations with quality management and risk management systems.
MedTech companies can achieve a competitive edge by early implementation of proactive PMS programs by heading off the tangible costs of down-stream field corrective actions and the very real, yet intangible, cost of customer satisfaction.
The SmartSolve team identified PMS as a key activity in a device manufacturer’s EQMS and has developed the SmartSolve Postmarket Surveillance module.
“Appropriate processes for collecting and analysing the information on the production and post-production feedback allow for early detection of any undesirable effects.”
Quote from ISO/TR 20416: Medical devices — Post-market surveillance for manufacturers
IQVIA SmartSolve® eQMS
SmartSolve Postmarket Surveillance provides best-practice processes for centrally managing all postmarket surveillance activities. The SmartSolve Dashboard organizes surveillance activities by task and task owner, to facilitate and improve tracking and cross-department communication, providing all team members visibility into the PMS process. Real-time status of tasks, and access to all surveillance evidence and reports, ensures team members always access current and accurate information.
Module Administration allows easy setup and maintenance of surveillance plans and activity details. Each surveillance activity and associated tasks are tracked from data collection through analysis and reporting.
SmartSolve Postmarket Surveillance integrates with other quality processes, including CAPA Management, Risk Management, and Change Management, providing closed-loop traceability across all quality processes. Integration with SmartSolve Document Management allows users to easily create PSURs and postmarket surveillance reports from custom templates and collaborate and review content with other team members.
SmartSolve Postmarket Surveillance is a complete solution for the PMS process, not only facilitating regulatory compliance, but effectively reducing cost and improving product safety and performance.
For more information about best-practice processes for centrally managing all postmarket surveillance activities, reach out to: Todd.Neal@us.imshealth.com or Caroline.Freeman@iqvia.com.
Connected, integrated, compliant. Build, scale, and optimize your quality and regulatory workflows with SmartSolve®, IQVIA's transformative Enterprise Quality Management System, built for Life Sciences.
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