Medical Device Complaints Handling Management-- One Of top Citations During FDA Inspection

Rita Hoffman

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This training program will discuss the basics of the Medical Device Complaint Handling Regulations and review the process for preparing to adequately establish and maintain procedures for receiving, reviewing, and evaluating complaints. We will explain proper handling of complaints. What is reportable or non-reportable to FDA for a product complaint, handling and documentation, how and when to file Medical Device Reports (MDR), and key factors in implementing and maintaining compliance under 21 CFR 803 regulations and real life experiences of FDA.

Course Objective

Medical device manufacturers must ensure that they have a well-designed system to address complaints related to their products. Components of a well-designed system include: process/procedure, trained personnel, and proper record keeping. Mistakes in identifying what is a complaint, overlooking information or warning signs of issues with can cause a company needless time and money to correct issues.

This webinar will explain:

  • What Constitutes a Complaint? 
  • Provide an overview and answer questions related to Complaints 
  • Provide general information regarding how to within your Firm on a Complaint
  • Establishing Complaint Files 
  • Help identify where you can find more detailed information on the preparation and transmission of complaints
  • When Does a Complaint Become MDR Reportable 

Course Outline

Basics of the Medical Device Complaint Handling Regulation
Establishing a Formal Designated Unit, What Personal is needed
How to define the process for receiving complaints
Define the process for reviewing complaints
Define the process for evaluating complaints
How long are files maintained by Firm?
Which System Works Best for Your Firm
Readiness for FDA Inspector

Target Audience

  • Complaint handling units
  • Auditors
  • Compliance officers
  • Consultants/service providers
  • Regulatory/legislative affairs professionals
  • IT department supporting complaint handling
  • Regulatory affairs reporting units

Webinar Events
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Rita Hoffman,

Rita Hoffman is the principal consultant for Regs & Recall Strategies, LLC, a consulting firm providing regulatory insight focusing on industry assistance on FDA compliance issues. Ms. Hoffman has been consulting with FDA firms on post marketing issues for the past 4 years. Prior to working as a consultant, Ms. Hoffman spent more than 36 years with the FDA. She retired in 2011 after holding the position of recall branch chief for the Center for Devices and Radiological Health (CDRH). She was responsible for oversight and review of all medical devices recalls with extensive knowledge of the legal authority of 21 CFR Parts 7 & 806, 803 and 820 of the Act. During Ms. Hoffman’s tenure with FDA, she served in several critical headquarter positions including: compliance officer, ombudsman, jurisdictional review officer, small business liaison, and policy analyst. Ms. Hoffman has a diversified knowledge encompassing FDA scientific, investigational and regulatory policy areas due to her in-depth understanding of FDA regulatory and compliance issues from the perspective of both FDA and regulated industry. Throughout her FDA career, she has provided guidance and clarified FDA requirements, to industry, foreign governments, public entities and FDA field personnel involving recalls, labeling issues, dietary supplements, pharmaceuticals, OTC drug products and combination products. Ms. Hoffman continues to collaborate with industry as an expert advisor and remediates on regulatory subject matters including drug/device for recalls, GMP and quality systems inspections/regulations, field safety alerts for drug products, MDR and complaint handling, and other matters. She has been hosting trainings with various FDA Regulatory Groups for over 4 years on, compliant handling, MDRs and recalls. Ms. Hoffman is regulatory certified by the Regulatory Professionals Society (RAPS) and holds a BS from the University of Maryland in addition to the many awards she has received from both government and industry.

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