The "Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems (Online Training Course: August 25-26, 2025)" has been added to ResearchAndMarkets.com's offering.

This seminar will examine Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as appropriate articles / Annexes of the EU's MDR, which require manufacturers to conduct post-market surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Section 522 is implemented in 21 CFR 822.

This formal post-market surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. A more generalized "post-market surveillance" / complaint handling is also a requirement under the device CGMPs, 21 CFR 820, -.100 - CAPA, and -.198 - Complaints.

Data collected under post-market surveillance helps to address important public health questions on the safety and effectiveness of a device, often resulting in improvements in device design and manufacture. Similar requirements exist in the EU's MDR, as part of the final "Clinical Phase".

Why You Should Attend

For global companies, compliance with US FDA 21 CFR 820, known as The QSR (Quality System Regulation), is non-negotiable to market devices in the United States. Meeting these requirements necessitates passing FDA compliance inspections. Central to this compliance is addressing post-market use issues, including complaint handling and CAPA (Corrective and Preventive Actions).

The FDA mandates that companies implement robust programs to capture and address post-market problems and non-conformances. Such efforts minimize risks to users and patients and facilitate ongoing product enhancements. Failure to comply with these requirements can result in the classification of products as adulterated, triggering 483 Observations or Warning Letters that could severely impact business operations.

This two-day seminar is structured to guide attendees through FDA requirements and practical approaches for developing a CGMP-compliant post-market surveillance and complaint-handling system. It will address essential components and how Medical Device Reporting (MDR) and handling of adverse events integrate into this system.

Participants will gain crucial insights into maintaining compliance, thus ensuring the safety and effectiveness of their medical devices, while meeting both US and EU regulatory expectations.

Who Should Attend:

• Senior management
• Regulatory Affairs
• Quality Assurance
• Production
• R&D and Engineering
• All personnel involved in the U.S. FDA-regulated medical device development, manufacture, and post market activities. Especially those involved in new medical device / combination product development, non-conformances and field problems / complaints, line extensions, and incremental product improvements; having to evaluate those changes in light of the DHF / CGMPs, and then document these actions in harmony with the regulations.

Course Agenda

Day 1:

Introduction (personal/course information)

Session 1 - US FD&C Act Section 522 and 21 CFR 822

• "Post-market Surveillance under Section 522 of the Federal Food, Drug, and Cosmetic Act", Guidance, dated October 2022
• 21 CFR 822 - Implementing Sec. 522 of the FD&C Act - The Law/Requirements - Class II and III Devices

Session 2 - US FDA's Post Approval Studies (PAS) Requirements

• PAS Requirements and PMAs
• PAS Orders
• PAS Protocols
• Interim and Final PAS Reports
• Report Evaluations

Session 3 - FDA's Voluntary Summary Malfunction Reports

• Medical Device Reporting/Adverse Events (MDRs)
• The Voluntary Summary Malfunction Reports

Session 4 - CAPA/Trending

• Internal "Complaints" - NCMRs, OOS'
• External Complaint Handling
• CAPA Documentation
• CAPA Trending

Q&A

Day 2:

Review of Day 1 - Key Points

Session 5 - Failure Investigation, Root Cause Analysis

• Failure Investigation Tools
• Root Cause Analysis - Methods and Tools
• Communication
• Reports
• CAPA Trending

Session 6 - Risk Management and Human Factors

• Patient Hazard/Risk Management per ISO 14971:2019
• QMS/System Level
• File/Review (Benefit/Risk)
• Narrative/Descriptive Information
• Hazards, FTA, D-, P-, U-FME[C]A + Normal
• FDA Use/Human Factors Requirements
• Use Engineering Process - 9 stages - IEC 62366-1

Session 7 - Cybersecurity, Especially Post-Market

• Cybersecurity Requirements
• Threat Modelling .
• Post-Market Cybersecurity

Session 8 - Project Management Tools ( slides)

• Gantt Chart
• CPM Network Diagram
• PERT Network Diagram
• Post-Market Surveillance Usage

Review/Conclusion; Q&A

For more information about this training course visit https://www.researchandmarkets.com/r/g822ot

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