Understanding FDA Requirements to Manufacture & Market Medical Devices in the USA (from QMSR and beyond)

Understanding FDA Requirements to Manufacture & Market Medical Devices in the USA (from QMSR and beyond)

Course Duration: 1 Day

This one-day seminar addresses elements of the FDA’s requirements for manufacturing medical devices intended for release within the United States (US) market. The FDA has amended 21 CFR 820 to utilize the Quality Management System Regulation (QMSR) requirements which incorporates by reference (IBR) ISO 13485 to align more closely with international standards for medical devices. This course aligns regulatory understanding of the framework for the US market with the standard ISO 13485 used by other global regulatory authorities to promote consistency in the regulation of medical devices and provide a more expedient introduction of safe, effective, high-quality devices to patients

In addition, there are FDA requirements beyond the QMSR that are perhaps not well understood. This course will therefore clarify these areas to aid the participant in becoming familiar with these requirements in an unintimidating environment than a typical regulatory affairs atmosphere.

Please note: This course does not address the incorporation of ISO 13485 and the QMSR in detail. Omnex offers a separate class titled: Understanding the Requirements of ISO 13485:2016 Including the Interrelationship of FDA 21 CFR 820 Requirements for Medical Device QMS/QMSR.