Necessity of continuous follow-up of performance evaluation after sales of “PMPF” by manufacturers of laboratory equipment and products

Continuous follow-up of post-sales performance evaluation (PMPF): Due to the necessity of continuous follow-up of post-sale performance evaluation (PMPF) and its requirement in the new product conformity assessment regulations in the world, medical equipment manufacturers are required to define the plan and implementation procedures of PMPF as part of the after-sale monitoring system program. (PMS) are This plan must be implemented and documented in the technical file. For this purpose, manufacturers can refer to the attached guidance documents. Importance of PMPF PMPF is a process that continuously evaluates the performance, safety and effectiveness of medical devices throughout their useful life. This process is essential to identify and manage equipment-related risks, ensure ongoing compliance with regulatory requirements, and continuously improve product quality. Components of PMPF PMPF includes the following: Data collection: Manufacturers must collect data on equipment performance from a variety of sources, such as adverse event reports, clinical studies, user feedback, and maintenance data. Data analysis: Collected data should be regularly analyzed to identify patterns and trends and identify potential risks. Corrective Actions: If any hazards are identified, manufacturers must take appropriate corrective actions, such as updating labeling, issuing product recalls, or modifying product design. Documentation: All PMPF-related activities must be fully documented to be traceable and verifiable. Benefits of PMPF PMPF has several benefits for manufacturers, users and patients, including: Improved patient safety: PMPF helps identify and manage risks associated with medical devices, thereby improving patient safety. Improving product quality: PMPF helps manufacturers to identify product weaknesses and improve the quality of their products. Reduced Legal Liability: PMPF helps manufacturers reduce the legal risks associated with their products. Increase patient satisfaction: PMPF helps manufacturers offer products that better meet patients’ needs, thereby increasing patient satisfaction. Conclusion PMPF is an essential process for medical device manufacturers that helps ensure the safety, performance and effectiveness of their products throughout their useful life. By implementing a PMPF, manufacturers can manage risks, improve the quality of their products, and increase patient satisfaction.