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
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
Who will Benefit:
This seminar course will be beneficial for the following personnel in medical device manufacturing companies and in medical device supply chain:
Quality assurance and quality control
Regulatory affairs managers
Regulatory affairs professionals
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.
Use coupon code NB5SQH8N and get 10% off on registration.