A Comprehensive View of FDA Regulations for Medical Devices: 2 - Day In-Person Seminar

Don’t let a common misunderstanding get you into trouble! There is more to the US Medical Device Regulations than Part 820.

Companies that don’t understand will face regulatory scrutiny and receive FDA Form 483s and Warning Letters. Recently a device manufacturer got a Warning Letter relating to updates to shipped devices, which said, “The Quality Manager stated he was unaware of the corrections and removal reporting and recordkeeping requirements.”

This two day interactive course on FDA regulations for medical devices will:

• Cover more than just the Quality Management System
• Provide an overview of regulations and how they fit together
• Explain Unique Device Identification (UDI) in detail, covering the issues device manufacturers will face as well as timeline for implementation
• Help attendees understand the four major elements of the US regulatory structure: laws, regulations, guidance, and consensus standards
• Teach the current device marketing regulations
• Discuss how to handle FDA inspections and effectively respond to inspectional observations and 483s

• Learn the law, regulations, and policies that FDA applies for medical device
• Understand the requirements to market a medical device in the US 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 how UDI will affect medical devices and how to prepare for implementation
• Understand the rules for Medical Device Reports (MDRs) and their relationship to complaints
• Understand which devices must be tracked and how to set up and audit the system
• Learn about correcting devices already shipped and when to report to FDA
• Learn the role of FDA Inspections, the use of QSIT, and the possible outcomes of an inspection
• Learn about inspectional observations and how to respond to a Form 483
• Understand the issues manufacturers face by reviewing Warning Letters related to the topics covered

This seminar course will be beneficial for the following personnel in medical device manufacturing companies and in medical device supply chain:

• Quality managers
• Quality engineers
• Quality assurance and quality control
• 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
• CAPA team members
• Device marketing personnel

In the US, medical devices organization uses risk classes and panels. Devices 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 for 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 for complaint management to medical device reports to recalls. Each of these requirements is in a separate part of the regulations.

This two day highly interactive seminar will provide attendees a comprehensive view of the U.S. medical device regulatory requirements and will help them understand the whole picture and provide them with the effective implementation techniques for their organizations.