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Post Market Surveillance Needs To Be Robust To Avoid Penal Regulatory Action
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Post market surveillance (PMS) is a very important activity for manufacturers of medical devices. It needs utmost care in handling, because the FDA considers post market surveillance as one of its primary means for protecting public health.
Post market surveillance is, in simple terms, the monitoring of the performance and quality of a medical device after it has been released into the market. Although this is a very long phase which lasts till as long as the patient uses the product or it gets recalled; post market surveillance is necessary because a problem can arise at just about any stage of the product’s life.
Post market surveillance is built on many well-established principles of safety
Being a well-established discipline, post market surveillance is built on many well-established principles of safety. Some of the foundations on which the principles of post market surveillance are built are:
o Unique device identifiers (UDI)
o Electronic health records
o Medical device reporting
o Device registries, and
o Advance methods for evidence generation and data analysis
Despite the application of such concepts as mentioned above; post market surveillance is a discipline that is still evolving. So, given the primacy of its role in being a tool for protection of public health; those in charge of post market surveillance in medical device manufacturing companies need to be aware of what it takes to develop the capabilities for putting a foolproof post market surveillance system in place.
A learning session on how to get PMS right
The ways of doing this will be the content of a meaningful webinar that is being organized by Compliance4All, a leading provider of profession trainings for all areas of regulatory compliance.
Susanne Manz, an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma, and who brings an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities, will be the speaker at this webinar.
To derive the benefit of Susanne’s rich experience with medical devices and to understand how to develop a program for solid post market surveillance, just visit http://www.compliance4all.com/control/w_product/~product_id=501156LIVE/~sel=LIVE/~Susanne_Manz/~Spotlight_on_Post_Market_Surveillance
Susanne will give an understanding to participants of the importance of ensuring product safety and its attendant patient safety at this session. She will analyze the fundamentals of this discipline and show how a medical device company can develop one of its own and develop the capabilities for a sound post market surveillance program.
This webinar will help participants build a PMS that will help arm them with the means of acquiring important information about the medical device, which will help reduce the adverse events.
Susanne will cover the following areas relating to PMS at this webinar:
o Overview and Definitions
o FDA Expectations, Regulations
o Lessons Learned and Enforcement Case Studies
o Medical Device Reporting
o Investigating a complaint or MDR
o FAERS–FDA Adverse Event Reporting System
o Common Mistakes and how to avoid them
o Preparing for an FDA or NB Inspection
o Best Practices.
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