The medical industry is one of the most regulated fields. There are several regulatory bodies have been established to ensure that manufacturers of medical equipment design, and produce quality, effective medical devices. The products used in hospitals should not cause adverse health consequences. It is, therefore, crucial to access the effectiveness and safety of all the medical devices, especially those implanted on the patient’s bodies. The EU MDR PSUR template can guide you in conducting post-market surveillance for your medical devices.
Companies that manufacture medical equipment in Europe and America are required to conduct Post-Market Surveillance to ensure that their products are effective, safe for use. This surveillance can help these companies in coming up with products that enhance the patient’s safety and minimize any possible risk. A systematic procedure is used to collect information from hospitals and patients using these devices. The necessary preventive or corrective actions are applied in case there is a device that does not meet the required standards or that poses any risk to the customers. Manufacturers of medical equipment are required to perform test and studies of low-quality or high-risk medical devices and then make the necessary improvements on their medical equipment or products.
What to Include In a Post-Market Surveillance Report
As mentioned earlier, it is a requirement for all the manufacturers of medical equipment to conduct a PMS. A report that summarizes the conclusion and results of the data gathered is then prepared. This report should include all the possible corrective and preventive actions that need to be taken. Furthermore, this report should be adjusted or updated when necessary.
Data Collected Must Meet PMCF Requirements
The data collected from PMS should meet PMCF requirements. A PMCF consists of the data collected from complaints, vigilance system, publicly available information, complaints and technical information. One can also collect relevant data by screening scientific literature and getting feedback from users. PMCF requires manufacturers of medical equipment to use appropriate methods and procedures when collecting and evaluating their data.
PMS Requirements Imposed by Risk Management and QMS Standards
The risk management standard and ISO quality management standards are known for embracing the concept of post-market surveillance. A PMS is, therefore, an essential element of a quality management system. ISO 13485 requires the manufacturers of medical devices to ensure the overall safety and effectiveness of their medical devices. They also have a chapter that guides these companies in collecting and processing the data required. The data captured should include both the post-production and production activities.…