Exclusive NSF Whitepaper: Post Market Surveillance
What You Need to Know to Ensure Patient Safety
An overwhelming 60% of FDA citations from FY22 to FY24 centered on Post Market Surveillance, making this an issue that companies cannot afford to take lightly. It is crucial not only for patient safety but also for meeting regulatory standards and ensuring manufacturer accountability.
In this detailed guide, we examine the role of post-market monitoring, explore the regulatory landscape governing it, and provide expert advice on implementing a robust PMS framework including:
- What Are the Regulations Governing Post - Market Surveillance?
- United States: FDA Regulations and European Union: MDR Requirements
- Five Steps to Establish an Effective Post-Market Surveillance System
- The Importance of Corrective and Preventive Actions (CAPA) in PMS
- Medical Device Reporting
- Recalls/Corrections and Removals
To download Post-Market Surveillance, What You Need to Know to Ensure Patient Safety, please complete the following form.
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