What are the Key Components of Post Market Surveillance?
PMS typically involves several key components:
Adverse Event Reporting: Healthcare providers and patients report any complications or side effects associated with a product. Registry Data: Maintaining databases of patients who use specific devices or treatments to track long-term outcomes. Clinical Studies: Conducting follow-up studies to gather more data on the product’s performance. Periodic Safety Update Reports (PSURs): Manufacturers periodically submit reports summarizing safety data. Risk Management: Identifying and mitigating risks based on the collected data.
