Managing Medical Device Complaints - Webinar CD/Transcript

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Managing Medical Device Complaints

Complaint management is one of the most frequently cited QSR violations in warning letters.

An effective complaint management system must be compliant with several requirements including:

  • QSR
  • Medical Device Reports
  • Unique Device Identifier 

Manufacturers need to establish top-rung complaint procedures as well as creating records and documents that ensure smoothly functioning QMS along with FDA compliance.

Join industry expert Dan O’Leary for an in-depth review and analysis of FDA inspection techniques, QSIT and warning letters.

He will provide practical, real-world tips on the:

  • QSR definition of a complaint
  • Requirements to investigate a complaint
  • Qualification requirements for people who investigate complaints
  • Data elements for every complaint investigation
  • Effect of UDI on these required records
  • Connection between complaints and medical device reports
  • Connection between complaints and risk management
  • Differences in ISO 13485:2003 and ISO 13485:2016
  • Trend analysis requirements in the EU Vigilance system and when to report complaints

Order today for a concrete understanding of how complaint files are managed across both domestic and international facilities.

Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:

  • Quality Managers
  • Quality Engineers
  • Quality Auditors
  • Regulatory Managers
  • Complaint Handling Specialists
  • Data Analysts
  • Adverse Event Specialists

Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years ofexperience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.