Dublin, Sept. 23, 2026 (GLOBE NEWSWIRE) -- "2 Day Virtual Seminar - Medical Devices: Developing Effective Post Market Surveillance and Complaint Handling Systems (Aug 4th - Aug 5th, 2026)" has been added to ResearchAndMarkets.com's offering.
This regulatory compliance seminar provides an in-depth examination of U.S. Food and Drug Administration expectations for medical device postmarket surveillance and complaint handling. The program will address the regulatory controls manufacturers must establish to identify safety concerns, evaluate product performance, investigate complaints, manage corrective and preventive actions, and maintain compliance throughout the medical device lifecycle.
A principal focus will be Section 522 of the Federal Food, Drug, and Cosmetic Act and its implementing regulation, 21 CFR Part 822. Section 522 authorizes the FDA to require postmarket surveillance for certain Class II and Class III medical devices at the time of approval or clearance or at a later point. The seminar will review the circumstances that may lead to a Section 522 order, surveillance plan development, FDA submission requirements, data collection methods, reporting obligations, and manufacturer responsibilities for responding to agency feedback.
Participants will also examine how postmarket surveillance aligns with FDA Current Good Manufacturing Practice requirements and the Quality Management System Regulation under 21 CFR Part 820. The discussion will reflect the FDA's incorporation of ISO 13485:2016 into the Quality Management System Regulation, including requirements relevant to complaint handling, nonconforming product, risk management, corrective action, documentation, and regulatory reporting. The course will address how organizations can maintain effective complaint management processes while demonstrating appropriate investigation, escalation, trending, and management oversight.
Key topics covered during the seminar will include:
- FDA authority and manufacturer obligations under Section 522 of the FD&C Act and 21 CFR Part 822
- Quality system expectations for medical device complaint handling and postmarket data management
- Complaint intake, documentation, evaluation, investigation, closure, and record retention
- Determination of Medical Device Reporting obligations under 21 CFR Part 803
- Integration of complaint data with risk management, corrective action, and product improvement activities
- Identification of recurring failures, adverse trends, and potential safety signals
- Preparation for FDA inspections involving complaint files and postmarket surveillance records
- Management review and oversight of postmarket performance information
- Alignment of U.S. requirements with European Union Medical Device Regulation obligations
The seminar will also address post-market surveillance requirements under Regulation (EU) 2017/745, including Articles 83 through 86 and Annex III. Relevant requirements for post-market clinical follow-up under Annex XIV, Part B, will be considered as part of the broader clinical evaluation and post-market evidence framework. Discussion will include post-market surveillance plans, periodic safety update reports, post-market surveillance reports, vigilance, trend reporting, clinical evidence, and communication with competent authorities and notified bodies.
Particular attention will be given to the relationship among complaint handling, postmarket surveillance, CAPA, risk management, and regulatory reporting. Manufacturers must ensure that postmarket information is reviewed systematically and that significant findings are incorporated into product risk assessments, clinical evaluations, labeling, manufacturing controls, and design or process changes when required. Weaknesses in these interconnected systems may contribute to inspection observations, regulatory action, delayed reporting, recalls, or failures to identify emerging product risks.
This seminar is intended for regulatory affairs professionals, quality assurance personnel, complaint handling teams, postmarket surveillance specialists, clinical affairs personnel, risk management professionals, medical device engineers, internal auditors, and managers responsible for FDA or EU MDR compliance. Attendees will gain practical insight into building a compliant, inspection-ready postmarket surveillance and complaint handling program that supports patient safety, product effectiveness, and continuous quality improvement.
Who Should Attend?
This course is ideal for professionals involved in the development, manufacture, and post-market activities of U.S. FDA-regulated medical devices, including:
- Senior Management - overseeing compliance and product safety.
- Regulatory Affairs - ensuring adherence to FDA regulations and guidance.
- Quality Assurance (QA) - managing compliance, audits, and corrective actions.
- Production - implementing compliant processes and monitoring product quality.
- R&D and Engineering - developing new devices, combination products, line extensions, and incremental improvements.
It is especially beneficial for personnel handling:
- New product or combination product development
- Non-conformances, field complaints, and post-market issues
- Evaluating product changes in accordance with the Device History File (DHF) and Current Good Manufacturing Practices (CGMPs)
- Documenting actions to meet regulatory requirements
For more information about this training visit https://www.researchandmarkets.com/r/vwd5ry
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