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Post-Market Surveillance and Vigilance

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Post-Market Surveillance and Vigilance

Training Post-market surveillance (PMS) impacts all aspects of the quality management system. Including proactive and reactive information sources, incorporating post-market surveillance into your procedures for all products is a legal requirement. By developing a plan for post-market surveillance, you can target information sources that provide cost-effective and successful product launches. Accurately obtaining post-market information ensures continuous compliance with directives and identifies consumer needs that allow for ongoing product development. Upon completing this training, participants will be able to: Manage the regulatory requirements for PMS directives specific to a product class. Create and implement a procedure that includes both proactive and reactive information sources. Conduct cost-effective and targeted post-market clinical follow-up using various tools and techniques. Report adverse events in a timely manner with appropriate documentation.

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