Understanding US FDA QSR (21 CFR Part 820), Medical Device Reporting (21 CFR Part 803), Pre-Market Notification 510K (21 CFR Part 807)

Objectives

The course objective is to allow the participants to have an overview of the regulatory requirements for medical devices and a good understanding of US FDA QSR (21 CFR Part 820) requirement so as to achieve compliance witth FDA's Medical Device Quality System Regulation (QSR). In order to help to the participants to better equip when placing products in the US market, we have included understanding of Medical Device Reporting (21 CFR Part 803) and Pre-Market Notification 510K (21 CFR Part 807) in this 3 days training program.

This 3-days course is designed primarily to provide participants with a detail understanding of US FDA QSR (21 CFR Part 820) requirement, MDR and Pre-Market Notification 510K requirement. In addtion, upon successful completion of the course, participants will:

• Be able to effectively plan, prepare and review the current management system to comply withUS FDA QSR (21 CFR Part 820) requirement

• Be able to plan, document and prepare to meet the obligation for Medical Device Reporting in 21 CFR Part 803

• Be able to know the requirements for 510K submission and the information requested in 21 CFR Part 807.

Audience

• Managers, Executives, Regulatory personnel and those who are involves in compliance to FDA requirements for placing products in the US market

• Personnel who are involved in the implementation and maintenance of the quality management system in accordance to Quality System Regulation 21 CFR 820.