Post Market Topics for Medical Devices

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