Although a number of factors have lead to the 510(k) clearances, industry veterans feel that it is important for medical device manufacturers to understand the recent changes (hurdles and new requirements) and be able to prepare a 510(k) in a sufficiently adequate way to expedite the review process and successful clearance without delays.
In this power-packed conference, join our expert, Dr. David Lim, Ph.D., RAC, ASQ-CQA, as he discusses what and how to do with your 510(k) preparation and submission. He will also share what he has learned from his own experience based on his analysis of recently cleared 510(k)s.
You will learn how to demonstrate due diligence activity when contemplating a 510(k) submission, how to prepare a 510(k), submit and clear it in accordance with FDA’s eCopy and RTA policy so that your time, energy and financial resources can be effectively used to accelerate your 510(k) clearance, potentially saving millions.
Here's a look at what David will cover:
Who should attend?
RA, R&D, QA/QC/QS, CROs, Consultants, Contractors/subcontractors, Senior management, Anyone interested in 510(k) matters
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.