Post-Marketing Surveillance Support for Medical Devices
Medical device post-marketing surveillance is an ongoing process that aims to monitor the safety and effectiveness of medical devices after they have been approved and are on the market. It allows for the identification and management of safety and performance issues that may not have been identified during the approval process. PMS helps device manufacturers to monitor a device’s real-world risk continuously and implement necessary changes in real-time. PMS actively and systematically gathers, records, and analyzes relevant data on quality, performance, and safety throughout the device’s entire lifecycle.
With over 15+ years experience, our Pharmacovigilance team has helped several medical device companies with the following services:
How We Can Help
At Techsol, our expert team of Pharmacovigilance professionals have an extensive research background, scientific knowledge, and ample experience in supporting post-marketing surveillance programs for global pharma companies.
Following are the key focus areas where have the expertise to deliver high-quality services throughout the device lifecycle as per applicable regulatory guidelines:
We can support data collection from a variety of sources, including adverse event reports, clinical studies, and post-market surveillance studies. This information is collected by the medical device manufacturer, regulatory agencies, healthcare providers, and patients.
Once the data is collected, our team of Pharmacovigilance experts can analyze and identify any patterns or trends that may indicate safety or performance issues with the medical device. This analysis may involve statistical methods and data visualization techniques.
Based on the data analysis, a risk assessment is conducted to determine the severity and likelihood of harm associated with any safety or performance issues. This assessment may also consider the potential benefits of the medical device and the availability of alternative treatments.
MEDICAL DEVICE POST-MARKETING SURVEILLANCE
If safety or performance issues are identified, a risk management plan is developed to mitigate or eliminate the risk. This plan may involve changes to the labeling or instructions for use of the device, modifications to the device itself, or withdrawal of the device from the market.
If required by regulatory agencies, medical device manufacturers are responsible for reporting any safety or performance issues to the appropriate regulatory agency. These reports must include details of the issue, the risk assessment, and the risk management plan.
PMS Safety Monitoring
The medical device post-marketing surveillance process is ongoing, and the device’s safety and performance are continually monitored. As new information becomes available, the risk assessment and risk management plan may need to be updated.