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Once a medical device is commercialized, FDA requirements mandate that a company must perform Post Market Surveillance (PMS) to ensure public safety and efficacy.

This course will provide a detailed training on a variety of Post Market Topics and will introduce professionals to the many typical situations they may be responsible for during the weeks, months and years after commercialization of a product. Learning will be done by studying regulations, investigating the history of other companies (particularly failures), and sharing experiences within the class.

Topics Include:

* Complaint Management
* Failure Investigations
* Recalls
* Internal Audits
* Inspection Management Marketing Material

Practical Skill Development:

* How to manage complaints
* How to decide between a recall or enhancement
* Do’s and Don’ts during an FDA inspection
* Tools used to improve internal audits
* Best Practices for Marketing Materials
* Tools to protect company from off-label promotion

Course Number: BIOL-40326
Credit: 3.00 unit(s)
Related Certificate Programs: Regulatory Affairs for Medical Devices

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