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Understanding post-market surveillance requirements for medical devices (US & EU markets)
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- Understanding post-market surveillance requirements for medical devices (US & EU markets)
- Guidance for post-market surveillance and market surveillance of medical devices, including in vitro diagnostics
- Biomarkers as drug development tools: discovery, validation, qualification and use
- Clinical Biomarkers in Drug Discovery and Development
- Non-Inferiority Clinical Trials to Establish Effectiveness
- FDA Approval Process
- Three tools that help medical device SMBs work remotely
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Understanding post-market surveillance requirements for medical devices (US & EU markets)
[/vc_column_text][vc_column_text]Medical device vigilance is concerned with device issues (incidents), their analysis, and mitigation to preserve device performance and patient safety. The major goal of this is to describe the parameters of the medical device vigilance program and emphasize the requirements that still exist in state laws of regulated markets (US & EU), and improve access to safe, dependable, and therapeutic advantages. Before marketing, the manufacturer should do a risk assessment based on the severity of the subject. In the United States, Medical Device Surveillance is concerned with post-marketing monitoring. The manufacturer or importer must submit reports to regulatory authorities, as is the case in the European Union. The US medical device tracking system collaborated with several departments to update adverse event data. The user or maker must report events to member states as soon as feasible to prevent or decrease the risk of casualty or serious degradation in terms of safety and quality by applying the CAPA for risk analysis.
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Objectives
- To reduce the possible danger of usage, ensuring that the intended consumer can use the medical equipment safely and effectively throughout the product’s life cycle.
- Identifying possible design-related hazards in both normal and liability situations
- To assess the risks of medical devices through risk analysis and control strategies.
The advantages of doing risk analysis during the design of medical devices can be significant. They can be utilized to compensate for part or all of the costs of implementing risk reduction measures. Manufacturers must be aware of and understand the vigilance reporting requirements of all countries in which they operate. A robust, well-documented, compliance vigilance reporting procedure is required to verify that their medical equipment continues to work as planned, performs as expected, and remains snipping.[/vc_column_text][vc_column_text]
References
Shashank, N., et al. “Vigilance System Requirements across US and EU for Medical Device.” INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 11.03 (2020): 435-438.[/vc_column_text][/vc_column][/vc_row]
