Art of Compliant Handling Challenges for Medical Device

Overview:

Manufacturers of any class of medical devices are NEVER exempted from the Quality System regulation complaint requirements (820.198) or the general record requirements (820.180) which permit FDA review and copying of these records. Medical Device firms and Designated Agents for foreign firms don't understand the entire realm of the complaint process. Learn what it takes to stay in compliance and avoid risk to your products being removed from the market once you have received your PMA or 510(k).

This presentation is hosted by an expert in providing and outlining current Medical Device Complaint Handling Procedures and how to review and process them for next steps in post-market evaluations.

This webinar will:

• 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

You will come away with a broad understanding of steps to track and trend overview of complaint process and common mistakes and potential consequences of non-compliance during review.

Why should you Attend: 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.

Areas Covered in the Session:

• Up to date information to help you understanding the meaning of a complaint
• Identify poor performance in the overall quality system
• Aid in implementing solutions to quality problems
• Verify confidence in and improve your complaint handling unit
• When a complaint turns into a medical device reporting (MDR)
• Reduce employee confusion
• Improve customer relations by reducing the frequency of problems, complaints, and results
• Assure compliance with device regulations and consensus standards

Who Will Benefit: This course will benefit anyone in the Medical Device industry that handles functions involving Product Complaints, Recalls, Medical Device Reporting.

• Regulatory Affairs
• QA/QC
• Project Managers
• Regulatory Professional
• Risk Managers
• Complaint Handling Teams
• CAPA Teams

Speaker Profile
Rita Hoffman is the Principal Consultant/Owner of Regs & Recall Strategies, LLC, and 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 6 years. Prior to working as a consultant, Ms. Hoffman spent more than 37 years with the FDA.