Post-Market Surveillance (PMS): Performance Monitoring of Medical Devices

Post-Market Surveillance (PMS) for Medical Devices

Post-Market Surveillance (PMS)

The collection of all processes and activities used to monitor the performance of medical devices is called Post-Market Surveillance (PMS). The need for PMS arises immediately after the commercialization of the device. However, in order to produce products in line with market expectations and legal requirements, it is of utmost importance that the preliminary PMS process is handled at the initial design stage of the product, especially with the available data that can be accessed through equivalent/similar products in the market.

PMS should generally be carried out in accordance with MEDDEV 2.12.1 Rev.8 and ISO 20416 Guidelines.

PMS work can be carried out in 2 ways.

Reactive
Proactive

Reactive PMS: The reactive collection of all necessary data, including complaints and adverse events related to the medical device, information on the quality, safety or performance of the device is called Reactive PMS. It covers the necessary work after the event occurs in the PMS process. This approach addresses the following issues.

Customer Complaints
User Feedback (Non-Complaint)
Maintenance / Service Reports
Quality Assurance routine tests and checks
Reporting of Adverse Events and Product Withdrawals Related to Medical Devices

Proactive PMS: In Proactive PMS, which covers activities before the event occurs, additional information on quality, safety and performance can be collected proactively through routine production batch verification tests/controls. The aim of proactive PMS is to identify safety and performance issues before the Medical Device reaches the consumer.

Examination of the manufacturer's data on adverse events related to their products and product withdrawals
Customer expectations and suggestions from customer feedback processes
Data on customer expectations and suggestions obtained from sales channels (dealers, distributors)
Process measurements and nonconformities
Examination of product withdrawals and adverse event notifications related to equivalent/ generic products available on the market
Examination of the data obtained from the quality control processes of the necessary tests and analyzes performed during and after production
Clinical literature review data
Periodic risk assessments
Post CE marking clinical trials, including PMCF (post-sale clinical follow-up), reviewing the current design and identifying the need for changes, if any, after the product is placed on the market

Nanolab Laboratories Group continues to provide services within the scope of Medical Device Analysis.

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