With this session by expert speaker, Dr. David Lim, Ph.D., RAC, ASQ-CQA, you will get familiar with the “Best Practices” to draft an FDA 510(k) including the Dos and Don’ts to it. The session will discuss the best practices to adequately put your 510(k) together for successful submission to the FDA, complying with the FDA’s eCopy and Refuse to Accept (RTA) policy.
The session will help you streamline the 510(k) preparation and submission processes at your firm for maximum benefits in an effective and least burdensome manner. Dr. Lim will share some inside tips based on his learnings and his experience including his analysis of 510(k)s, which has been recently cleared.
It is a must attend session for regulatory professionals, who are working in medical device industry, and those who are interested in the topic. The session will discuss about premarket notification (510(k)) and regulatory requirements. You will also learn how to put together a 510(k) package for submission and clearance from the FDA.
Who Should Attend
Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.