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

Learning Objectives:

• 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

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 managers
• Quality engineers
• Quality assurance and quality control
• Regulatory affairs managers
• Regulatory affairs professionals
• R&D managers
• R&D engineers

Dan O'Leary has more than 30 years of experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. Mr. O’Leary has a Masters Degree in Mathematics, focusing on logic and number theory. His professional experience relates to quality, regulatory, reliability, and operations management.

He is a regular speaker at international conferences including ASQ, ISM, and RAMS. Dan teaches courses in reliability methods, medical device regulations and practices, statistical methods, management systems (ISO 9001, FDA QSR, & ISO 13485), and project management. He is an ASQ Certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; he holds an APICS certification in Resource Management.

Phone Number :  +1-888-717-2436

Email Id :  referral@complianceonline.com