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How to Get That 510(K) Out Of The Way

4467
Duration : 60 Minutes
Jim Dunning,

Jim’s consulting career began in 2001 and has consulted in quality and regulatory for companies ranging from Fortune 500 medical device companies to start-up medical device companies. Over his career, he’s acquired a passion for start-up and small companies, especially those in regulatory distress. Jim has amassed significan Read more

The FDA provides a great deal of guidance on “how to market your device”. The problem is, the guidance is written in FDA speak, which is not always clear to industry in general, and it can seem especially unclear to small medical device companies that are new to FDA regulatory requirements. This seminar will focus on the 510(k) process, also known as the “Pre-market Notification”process, and add clarity to the FDA guidance. Additionally, five common pitfalls to avoid when developing a 510(k), will be shared in this webinar. Also, some key points on how to manage change as it relates to the cleared 510(k) will be shared in this seminar. Finally, how to avoid FDA compliance problems once your 510(k) is cleared, because the problems you can face after you begin marketing a product are far greater than problems you face getting market approval.

Course Objectives:

• Learn about the key components of the 510(k) process, also known as Premarket Notification Process.   
• Learn about the five common pitfalls associated with the 510(k) process, and how to avoid these pitfalls
• Learn about the prerequisites needed to support the 510(k) development and notification (submission).
• Learn about key points to consider when choosing a laboratory, consulting firm, and or legal firm to help with your 510(k).
• Learn how to determine what your company’s total cost will be for 510(k) development and notification (submission).
• Learn about the post clearance (approval) requirements and how to avoid FDA regulatory problems once your product is on the market in the United States.

Course Outline:

• U.S. FDA Regulatory Requirements for the 510(k)
• Common pitfalls associated with the 510(k) process
• Prerequisites to 510(k) development and notification (submission)
• Costs associated with the 510(k) development and notification (submission)

What You Get:

• Training Materials
•  Live Q&A Session with our Expert
•  Participation Certificate
•  Access to Signup Community (Optional)
•  Reward Points

Who Will Benefit:

• Founder, Partner,CEO
• Chief Financial Officer
• Chief Operating Officer
• Engineering Manager
• Operations Manager
• Product Development Engineer
• Regulatory, Quality Vice President, Director, Manager
• Regulatory, Quality Specialist
• Small to medium sized medical device companies in the United States

Please reach us at 1-888-844-8963 for any further assistance or if you wish to register

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Subject : How to Get That 510(K) Out Of The Way

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