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Urgent Field Safety NoticeCADstream2016023/024 Field Safety Corrective Action Date:Attention: Radiology ManagerDetails on affected devices: CADstream versions earlier than 5.2.6. These versions were
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How to fill out post market surveillance content

01
Identify the relevant post market surveillance requirements for your product.
02
Determine the frequency of data collection and reporting.
03
Establish a process for monitoring and collecting post market data.
04
Analyze the collected data and assess any trends or patterns.
05
Document all findings and any actions taken in a post market surveillance report.

Who needs post market surveillance content?

01
Medical device manufacturers
02
Pharmaceutical companies
03
Healthcare providers
04
Regulatory authorities

What is Post Market Surveillance: Content of Field Safety Notices Form?

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Post market surveillance content refers to the information and data collected on the safety and effectiveness of a medical device or product after it has been released on the market. This includes monitoring adverse events, collecting feedback from users, and assessing long-term outcomes.
Manufacturers and sponsors of medical devices or products are typically required to file post market surveillance content to regulatory authorities to ensure compliance with safety and effectiveness requirements.
To fill out post market surveillance content, you need to gather relevant data on product performance, document any adverse events, compile user feedback, and complete the required forms specified by the regulatory body, ensuring that all information is accurate and submitted within designated timelines.
The purpose of post market surveillance content is to monitor the safety and effectiveness of medical devices or products after they are on the market, identify any potential risks, and ensure ongoing compliance with regulatory standards.
Information that must be reported includes adverse event reports, safety and performance data, user feedback, and any risk management updates relevant to the product.
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