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2 Day Medical Device Post-Market Regulations and Challenges Online Course: Complaint Handling, MDR Reporting and Recalls Course (January 26-27, 2023)

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Dublin, Dec. 30, 2022 (GLOBE NEWSWIRE) -- The "A Comprehensive View of Medical Device Post-Market Regulations and Challenges -Complaint Handling, MDR Reporting and Recalls Course" training has been added to's offering.

This course on Medical Device Complaint Handling Training aims at providing a close understanding of MDR & recall compliance. It also deals in handling the interrelationship of Complaint Handling, CAPA, and Risk Administration procedures.

Post-Market activities, Grievance Handling, MDRs, and Recalls are luxurious, time-consuming, and often lead to graver monetary penalties. Over 80% of FDA Inspection target observations for lack of compliance in these areas.

By attending this seminar, every trainee will be able to find out and discover:

  • Different ways to overcome one of the major hindrances device manufacturers encounters

  • How the FDA expects you to grow and device proper handling of complaints reportable or non-reportable, product complaint management and certification

  • How and when to file Medical Device Reports (MDR), actual and suitable message with the apt controlling agencies in the event of a recall.

  • How to demeanor improvement and elimination actions to avoid a recall emergency, including required recordkeeping, anticipation from FDA and other monitoring agencies in the event of a recall, and crucial factors in applying and upholding compliance with the regulations and real-life experiences of FDA.

New course materials have been added, and updated content now contains:

  • Creating Standard Operating Systems (SOPs) for Post-Market Quality Systems and

  • What to expect from the changes in ORA with Inspection Structure Realignment

  • This Seminar on Medical Device Reporting Training will have you stop spinning your wheels with supplementary actions, and leave you with a complete knowledge set that only WCS can provide.Who are the possible beneficiaries of this course in Medical Device Reporting Training?

Objectives of Learning- Medical Device Reporting Training

  • Knowledge of ways to comply with complex Complaint Handling, MDR, and Recall requirements

  • Companies' MDR reporting and FDA's management of reports

  • Company training in the event of a Recall, recall policy, notification letter, and interactive with the FDA

  • Diminish the risk of controlling implementation activities

  • Contribution to the creation and maintenance of real events for treatment complaints, reportable events, and recalls

  • Comprehend the relationship and interaction with other quality system elements as they relate to complaints and reportable events

  • Walk-through of case instances

  • A step-by-step guide to designing Standard Operating Systems for communicating processes for the success of the firm

  • Discussion of FDA's New Guidance on Risk and how it interacts with Recalls

Who Should Attend:

  • CAPA Teams

  • Quality Assurance

  • Regulatory Affairs

  • Risk Management Professionals

  • Quality Control

  • Project Managers

  • Regulatory Professional

  • Complaint Handling Teams

Key Topics Covered:

Session 1

  • Grievance Management and FDA Prospects (90 mins)

Break (15 mins)

Session 2

  • Continuance Grievance Treatment and FDA Expectations (30 mins)

  • Medical Device Reporting Procedures (MDR) Regulations, Procedures, and Malfunctions (60 min)

Lunch Break (45 mins)

Session 3

  • Continuation of Medical Device Reporting Events (MDR) Rules, Measures, and Malfunctions (60 min)

  • MDR reporting by the firm, agents Voluntary Malfunction Summary Reporting (VMSR), and eMDR Discussion (30 min)

Break (15 mins)

Session 4

  • Guidance Documents Update (30mins)

  • Being Recall Ready (30mins)

Questions and Recap (10 mins)

Session 5

  • Recalls, Definition, and Legal Authority Overview (60 mins)

  • Corrective and Preventative Actions (CAPA) (30 mins)

Break (15 mins)

Session 6

  • Health Hazard Evaluations HHE/HRA (30 mins)

  • Elements of a Correction and Removal - 806 Reporting (45 mins)

Lunch Break (45 mins)

Session 7

  • Developing Effective Strategies / Communicating and Negotiating with FDA (45mins)

  • Notifications Letters and Press Releases (20 mins)

  • Silent Recalls / Product Enhancements and Enforcement Actions (20 mins)

Break (10 mins)

Session 8

  • Product Retrieval (20 mins)

  • Status Reports (20 mins)

  • Effectiveness Checks Follow-up Planning (20 mins)

  • Terminating a Recall (15 mins)

  • Wrap-up (5 mins)

For more information about this training visit

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