Medical Device Vigilance

Medical device vigilance refers to the ongoing monitoring and reporting of adverse events associated with the use of medical devices to identify potential problems with devices and ensure their safety and effectiveness.

Both FDA and EMA have stringent Medical Device Reporting (MDR) regulations that outline the requirements for reporting adverse events and incidents related to medical devices. These regulations specify the information that must be reported, the timeframes for reporting, and the procedures for reporting. 

Under the MDR and IVDR, manufacturers, authorized representatives, importers, and distributors of medical devices are required to establish and maintain a post-market surveillance system. This system must include procedures for the collection and evaluation of data related to the safety and performance of their devices, as well as the investigation and reporting of serious incidents and field safety corrective actions. This includes monitoring and reporting of adverse events and incidents, as well as conducting studies and assessments to evaluate the performance of their products. In this aspect, device tracking and labeling plays an important role to track and identify products  in the event of a recall or other adverse event.

In addition, manufacturers must appoint a person responsible for regulatory compliance (PRRC) who is responsible for ensuring that the post-market surveillance system is established, implemented, and maintained in accordance with the MDR or IVDR.

The MDR also requires manufacturers to report serious incidents and field safety corrective actions to the European database on medical devices (EUDAMED). The reporting requirements include the submission of a summary of the incident or corrective action within 15 days, followed by a detailed report within 30 days.

Our team of experts provides a range of services to help you comply with regulatory requirements, mitigate risks, and ensure patient safety.

For Class I devices, we offer vigilance reporting and documentation services, including post-market surveillance, trend analysis, and event reporting. We provide guidance on the applicable regulatory requirements and assist with the preparation and submission of vigilance reports to regulatory authorities.

We provide support in the timely reporting of adverse events, complaints, and incidents associated with your medical devices. Our team will work with you to develop a robust vigilance reporting system that meets regulatory requirements.

We use advanced analytical tools to detect signals of potential safety issues associated with your medical devices. Our team provides timely feedback on potential issues and works with you to develop appropriate management plans.

Our team will conduct a risk assessment of your medical devices and develop a risk management plan to identify, evaluate, and mitigate potential risks associated with your products.

We offer comprehensive post-market surveillance services to monitor the safety and effectiveness of your medical devices in the market. Our team will analyze data from various sources and provide you with regular reports on the performance of your devices.

We provide regulatory compliance support to help you meet the requirements of different regulatory bodies across the world. Our team will work with you to ensure that your medical devices are in compliance with local regulations.

We ensure that your medical device vigilance activities comply with the applicable regulatory requirements, including the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR).

We offer quality management services to help you maintain the quality of your medical devices throughout their lifecycle. Our team will work with you to develop and implement quality management systems that comply with regulatory requirements.

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At our company, we understand the importance of patient safety and regulatory compliance. Our team of experts has extensive experience in medical device vigilance and can provide you with customized services that meet your specific needs. Contact us today to learn more about how we can help you ensure the safety and effectiveness of your medical devices.

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