It is important for pharmaceutical industry to accurately understand the enforcement authority of FDA for general purpose medical devices, medical device washers, washer-disinfectors and disinfectors, in particular which medical devices are exempt from or are required to submit the premarket notification 510(k) to the FDA for clearance.
This conference by expert speaker Dr. David Lim, Ph.D., RAC, ASQ-CQA will help you get familiar with the FDA requirements for medical device washers, washer disinfectors and disinfectors, which are intended for processing reusable medical devices for FDA clearance purposes.
You will learn how to understand and adequately implement the regulatory requirements for washers, washer-disinfectors, disinfectors or sterilizers from this session. Also, you will also get the opportunity to ensure that your processes are adequate and meet the regulatory compliance requirements and contribute to saving millions of various resources.
Who Should Attend
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.