Understanding Medical Device Reprocessing Requirements and Various Device Washing Technologies

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 minutes
Product Description

Get an Understanding of FDA Enforcement for Medical Devices, Device Washers & Disinfectors

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.

Session Highlights:

  • Laws And Regulations
  • Definitions
  • Regulatory Requirements For Washers, Washer-Disinfectors, Or Disinfectors
  • Applicable Standards
  • What all to include in Instructions for Use (IFU)
  • Various Medical Device Washing Technologies Available For Reprocessing Purposes
  • Requirements for Washing Systems of Cleaning Robotic Surgery System (e.g., Da Vinci Instruments)
  • What To Submit To The FDA For Clearance: Technical Documentation
  • Best Practices: Dos And Don’ts

Who Should Attend

  • People in the Global medical device and in vitro diagnostic device industry
  • People in the Global drug and biologics industry
  • Hospital Administrators
  • Hospital Infection Managers
  • Hospital Quality Control Managers
  • Hospital Risk and Complaint Managers
  • Financial/capital firms managing medical device products
  • Global healthcare regulators

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

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.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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