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 explains how the parts of the regulations fit together. The seminar helps 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 pre-market submission pathways 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.
After release, a device is subject to a variety of other requirements ranging from UDI to complaint management to medical device reports. Each of these requirements is in a separate part of the regulations.
This course provides a comprehensive view of the regulatory requirements to help you understand the whole picture and provide effective implementation for your company.
Why Should You Attend:
People who work in medical devices are not always able to see the complete structure of the regulations and how they fit together. In the US regulatory structure the parts are linked and intertwined. For example UDI implementation is in about six parts of the regulations. Medical Device Reports, in Part 803, must link with complaints in Part 820.
This course provides explains how all of this fits together. Whether you are an experienced professional or a person just entering the field, this seminar provides the information you need to understand and stay current with the US regulatory structure.
Areas Covered:
- Distinguish among the law, regulations, and policies that FDA applies for medical device
- The concepts of pre-market approval including device classification and pre-market submissions
- The quality management systems that govern the design, manufacture, installation, and servicing of medical devices distributed in the US
- The role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
- FDA’s inspection documentation tools including the FDA forms 482, 483, and 484.
- Utilization of Warning Letters to understand the regulatory issues
Who will Benefit:
While the course is specific for medical device manufacturers, any company in the medical device supply chain can benefit. It is ideal for:
- Quality Managers
- Quality Engineers
- Regulatory Affairs Managers
- Regulatory Affairs Professionals
- R&D Managers
- R&D Engineers
- Product Design and Development
- Operations Managers
- Production Managers and Supervisors
- Manufacturing Engineers
- Risk Managers
- Complaint system team members
- CA&PA team members
- Medical/Marketing Personnel
