Understanding the Requirements of ISO 13485:2016 and Interrelationship of FDA 21 CFR 820 Requirements for Medical Device QMS/QMSR

Understanding the Requirements of ISO 13485:2016 and Interrelationship of FDA 21 CFR 820 Requirements for Medical Device QMS/QMSR

Course Duration: 2 Days - 8 Hours/day

Omnex is an Exemplar Global Certified TPECS provider for Exemplar Global-MD Competency Unit. This two-day course has been developed to satisfy the Exemplar Global MD Examination Profile and, as such, all attendees who successfully pass the exams during this course will achieve a Certificate of Attainment for the following competency unit:

• Exemplar Global MD

This seminar fully covers the ISO 13485:2016 requirements. ISO 13485 specifies requirements for quality management systems in order to achieve regulatory compliance in the medical device sector.

Additionally, the FDA has amended the 21 CFR 820 Quality Management System Regulations (QMSR) to incorporate by reference the requirements of ISO 13485:2016 as well as define specific requirements for the QMSR. This course follows the framework of an ISO 13485 QMS, identifying the differences and requirements specific to the FDA QMSR to promote consistency in the regulation of devices and provide timelier introduction of safe, effective, high-quality devices to patients.

Please note: this course only the requirements from FDA pertaining to 21 CFR 820 as it relates to the QMSR. If you need in-depth training on the additional FDA requirements, Omnex offers a three-day course titled Understanding FDA Requirements to Manufacture & Market Medical Devices in the USA which includes all the content of this course as well as a third day that covers additional FDA regulations.