Best Practices in 510(k) Submissions

Targeted to the small company with limited RA/QA resources, or to the new RA/QA professional, this webinar will introduce the basic concepts and best practices of the 510(k) submission process. We will also discuss other communication tools such as the request for information (513g) and preIDE meeting.

Areas Covered in the Seminar:

• Best Practices in 510(k) Submissions
• Strategies for finding predicate devices.
• The three types of 510(k) submission and when they’re used.
• The benefits and drawbacks of using the 3rd party review process.
• Agency communication tools.
• What do I do if clinical data are reqiured for my 510(k)

Who Will Benefit:

• Regulatory Affairs
• Quality Assurance/Control
• Engineering
• Research & Development
• Quality Systems Management
• Documentation Management
• VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs

Instructor Profile:

William G. Mclain, RAC, B.S.E. is the President and Principal Consultant for Keystone Regulatory Services, LLC. He has over 15 years experience in product development, domestic and international regulatory affairs and risk management, and quality management system design in the medical device industry. He has contributed to the timely development and market introduction of cardiovascular, anesthesiology, gastroenteral, diagnostic and general surgical devices by providing regulatory, quality system and risk management strategy, oversight, and support. An active member of RAPS and ASQ Biomedical Division, Mr. McLain is RAC Certified and holds a BS in Mechanical Engineering from Grove City College.

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