ComplianceOnline, Grand Hyatt San Francisco 345 Stockton Street, San Francisco, CA 94108
2013-02-20
Course Description:The US medical device regulations include Part 820, the Quality System Regulation, but extend far beyond them. In order to understand the regulations, you need to look at more than just the quality management system. This course provides an overview and shows how the parts of the regulations fit together. The seminar will help you understand the four major parts of the US regulatory structure: laws regulations, guidance, and consensus standards. Risk class and the panels, established by law, characterize medical devices in the US. Device types fall under regulations and product codes that determine the available conformity assessment paths and provide requirements for specific cases. The Quality System Regulation, in Part 820, provides the quality management system required to market medical devices in the US. Device design, production, installation, and servicing fall under Part 820. This part of the regulations include management responsibility for the system, design requirements, purchasing, manufacturing processes and controls, release for distribution, record keeping, etc. Learning Objectives:- Learn the law, regulations, and policies that FDA applies for medical device.
- Understand the concepts of pre-market approval including device classification and conformity assessment paths.
- Understand the quality management systems that govern the design, manufacture, installation, and servicing of medical devices for the US market.
- Learn the role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection.
- Understand the FDA's inspection documentation tools including the FDA forms 482, 483, and 484.
- Understand the issues manufacturers face by reviewing Warning Letters related to the topics covered.
- Learn the status of the Unique Device Identification (UDI) rule and considerations for implementation.
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