The Values and Benefits of Medical Device Reporting Compliance

    /Les  /Schnollspeaker of compliance global
    Speaker: Les Schnoll
    Duration: 90 Minutes
    Product Code: 700039
    Level: Beginner
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overview

Since the mid 1980s, the FDA has expressed concerns about their need to be informed of adverse events that may have been caused by or contributed to legally marketed medical devices.  As such, they promulgated the Medical Device Reporting regulation, 21 CFR 803, in 1984. The regulation requires reporting, within designated time periods, any death or serious injuries that may have been attributed to the devices, as well as any malfunctions of the device that could result in a death or serious injury. Failure to comply with the regulation results in the marketed device being misbranded.  So – are Medical Device Reporting regulations merely an additional bureaucratic regulation or do they add value and benefit to the manufacturer?

why should you attend

Getting feedback on your products, both good and bad, is beneficial and can be an excellent learning experience.  However, hearing issues and concerns about your marketed medical devices and not doing anything about it can result in dire consequences for both patients and the manufacturer.  Failure to comply with healthcare regulatory compliance for customer complaints in itself can result in the FDA considering your products to be adulterated and/or misbranded; failure to follow processes that meet the FDA’s expectations can result in civil and criminal penalties, including fines and imprisonment!

This webinar will provide attendees with tools and techniques to help ensure that regulatory requirements for assessing complaints to determine if they constitute a reportable adverse event (MDR) and the processes that must be followed to report those incidents on a timely basis.  Voluntary compliance is not an option and complete understanding of the Agency’s requirements and expectations is of utmost importance to minimize potential future mandatory decrees to compel an organization to “do the right thing” and take appropriate actions to protect its customers and patients.

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Areas Covered

This session will discuss:

  • Medical Device Reporting History, Overview, and Basics 
  • Consequences for Non-Reporting and Over-Reporting
  • Definitions:  Serious Injury, Death, Malfunction, User Error, Reportable Event
  • When do malfunctions need to be reported?
  • The eMDR System
  • MDR for Manufacturers and Importers
  • MDR for User Facilities
  • The MAUDE Database

Learning Objectives

This webinar will assist the participant in:

  • Understanding the regulatory requirements for reporting medical device adverse events to the FDA
  • Obtaining clarity on constitutes a reportable adverse event (MDR)
  • Knowing what the potential penalties for not properly reporting MDRs

WHO WILL BENEFIT

  • Quality and Regulatory Managers
  • Quality and Regulatory Specialists
  • Complaint/MDR Coordinators
  • CAPA Coordinators
  • Medical Device Importers
  • Hospitals and Long Term Care Facilities
  • Pharmacies

SPEAKER

Les Schnoll has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.

Les is the Principal of Quality Docs, LLC, providing quality and regulatory services to the FDA-regulated and Arizona Department of Health-regulated industries. He is also currently an Instructor in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Device program in the College of Professional Studies at Northeastern University and a Faculty Associate at Arizona State University, College of Nursing and Health Innovation, in the MS Regulatory Science and Health Safety Program.

He was most recently the Vice President, Quality Assurance and Regulatory Affairs with the J.T. Posey Company and has held executive positions at ThermoGenesis, Theravance, Solectron, Hill-Rom, Gliatech, Cyberonics, Southern Research Institute, KPMG Quality Registrar, and Dow Corning Corporation. Les has conducted various training programs, audits, and systems development in the United States, Canada, Europe, South America, Russia, Australia, and the Pacific Rim.

Schnoll has written articles for such publications as Medical Design and Material, ISO 9000 Handbook of Quality Standards and Compliance, Pharmaceutical and Medical Packaging News, Food Quality, and Quality Progress. He is also the author of The CE Mark: Understanding the Medical Device Directives and The Regulatory Compliance Almanac, published by Paton Press.

Schnoll's professional affiliations include the American Society for Quality as a Certified Quality Engineer, Certified Quality Auditor, and Certified Quality Manager; the Regulatory Affairs Professionals Society as Regulatory Affairs Certified; the Institute of Certified Quality Consultants as a Certified Quality Consultant; the American Society for Microbiology as a Registered Microbiologist (clinical microbiology) and Specialist Microbiologist (consumer and industrial microbiology); and the International Register of Certified Auditors as a certified lead assessor.

He is a Fellow of the Chartered Quality Institute (formerly the Institute of Quality Assurance) and is accredited as a Chartered Quality Professional. Schnoll is also a former member of the United States Technical Advisory Group to Technical Committee 176, International Organization for Standardization and the United States Technical Advisory Group to Technical Committee 210, International Organization for Standardization. Les has a Bachelor of Science degree in biology from Ursinus College, a Master of Science degree in microbiology from Villanova University, a Master of Business Administration in human resources from Central Michigan University, and a Juris Doctor in health law from Concord University School of Law.

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