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 JOBSRegulatory requirements exist to ensure medical devices perform as intended, are safe for patients, and that the patient benefits outweigh any risks associated with using them. SmartSolve’s innovative new module offers risk management options that are key to post-market device surveillance. The module is designed specifically for regulatory purposes and empowers companies to operate safely and cost-effectively.
Global Requirements
Risk Management requirements differ somewhat between various regulatory authorities. For example, the European Union’s MDR explicitly requires companies to develop a risk management system and create a risk management plan for every device. The EU follows ISO14971 section 4.1, which requires a manufacturer to establish, implement, document, and maintain throughout a device’s life cycle, an on-going process for monitoring, controlling and measuring risk.
Meanwhile, although several FDA documents contain risk management requirements, FDA regulations only refer to the topic briefly. The FDA incorporates risk management requirements into the design, purchasing, and feedback processes. This language may strengthen as the FDA works to harmonize their regulations to ISO 13485:2016.
A product risk file is a key component of the risk management process, providing a single source for all records and documents applicable to risk management for a device. Systematically updating this file enables easy location of current records and documentation, ensures efficiency during auditing, and provides an effective means of traceability.
Just as risk regulations and guidance reference other standards, other regulations and guidance such as postmarket surveillance reference the need to perform risk activities to ensure that products are performing as expected. This makes risk an important part of the quality management ecosystem connecting risk to design control, change control, documents and postmarket surveillance.
SmartSolve’s Solution
The SmartSolve Risk Management module delivers an industry-recognized, best-practice solution with a product risk assessment process based on ISO 14971.
The product risk assessment process incorporates specific tasks that must be completed in order to build the Product Risk File. The process includes functions such as:
These actions identify the device’s intended uses, foreseeable misuses and characteristics relating to safety, as well as hazards, hazardous situations and harms, and related failure modes and root causes. Once this data is defined, it will be reviewed and may require an optional approval step based on the users’ business process.
The process then continues with the evaluation of risk, which establishes the product risk level and determines whether this level is acceptable or not. Risk control measures are then defined, along with any new risks resulting from the controls.
After defining risk control measures, an evaluation of residual risk and the risk benefit analysis takes place. If necessary, a user can discontinue the risk assessment or return to any of the previous steps in the process at any point during the review or QA submission.
On approval of the risk assessment, the product risk file is created or updated, and the risk level to the product or part is revised. If the risk assessment is an ad-hoc or periodic review, the process should include examining production and post-production information. Based on the product, this review includes data from various modules within SmartSolve, such as CAPA’s, Nonconformances, Complaints, Deviations, OOS, Inspection, and Audits. This post-production information, along with the expected risks identified for a product in Risk Management, provides insights for postmarket surveillance reporting.
Solution Benefits
The SmartSolve Risk Management module includes a number of other benefits, such as:
The risk assessment process is an ongoing way to identify hazards associated with a medical device. It allows users to estimate and evaluate associated risks, manage them, and monitor the effectiveness of risk control measures by reviewing production and post-production activities.
Promoting Best Practices
SmartSolve’s Risk Management module promotes best practices and is accepted globally by all major regulatory organizations. The iterative nature of the process drives continuous improvement and enables innovations that enhance product performance. Patient outcomes improve due to better safety, ongoing advancements, and superior performance.
Interested in exploring SmartSolve eQMS for your business? Reach out to us at Regulatory_Quality_Compliance@iqvia.com or visit our website here: IQVIA.com/SmartSolve.
Outdated compliance practices aren't viable amid evolving market and regulatory changes. IQVIA’s award-winning, end-to-end quality management system streamlines the product value chain, accelerates market entry, safeguards companies and patient safety, and meets complex regulatory demands.
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