Training Features

Understanding Medical Device Corrections, Removals and Recalls  

Gain a practical, end-to-end framework for managing medical device corrections, removals, and recalls across global regulatory markets.
Format

E-Learning

Level

Basic

Trainer

René Schings

Exam

Exam and certificate included

Duration

1,5 hours
9 modules

Price

€ 245 or equivalent currency

Course Overview & Description

In modern healthcare, ensuring product safety and maintaining regulatory compliance after a medical device enters the market is just as critical as the initial design and approval process. When unexpected quality deviations, software defects, or labeling errors arise, executing rapid, compliant field safety actions is essential to mitigate public health risks, fulfill legal obligations, and protect brand reputation.

This 1,5-hour foundational e-learning module provides participants with a clear, working knowledge of medical device field actions, including corrections, removals, recalls, and Field Safety Corrective Actions (FSCAs). Learners will explore global regulatory expectations across key jurisdictions, including US FDA, EU MDR, Health Canada, and ISO 13485 quality standards, while understanding the step-by-step lifecycle from initial issue detection through execution, closure, and preventive action.  
What You Will Learn
Who Should Attend?
What is Included?
Course Details
  • Differentiate between key regulatory terms: Correction, Removal, Recall, and Field Safety Corrective Action (FSCA).  
  • Identify high-level regulatory requirements and expectations from the US FDA, EU MDR, Health Canada, and ISO 13485.  
  • Recognize the signals for issue detection and outline how affected product scope and risk are initially evaluated. Understand why recalls are one of the most critical post-market activities for medical device manufacturers. 
  • Describe internal escalation pathways and decision criteria for standard vs. urgent field actions.  
  • Outline the required elements of a recall strategy, authority notification requirements, and end-user communications.  
  • Explain how field actions are executed, monitored, and verified for effectiveness.  
  • Summarize the criteria for recall closure, final authority reporting, and connection to the organization's CAPA system.  
  • Understand why recalls are one of the most critical post-market activities for medical device manufacturers. 
What is included in this e-learning?
  • Access to the Qserve Learn Training Portal
  • A training certificate upon completion of the training.
Access to any mentioned guidances or ISO standards that are not publicly available is not included in this e-learning.
  • Duration: Approx. 1,5 hours.
  • Format: Self-paced e-learning (video, interactive content, and quizzes).
Recommended Background (Optional): Basic familiarity with general medical device concepts or Quality Management Systems (e.g., ISO 13485 design or change control principles) is helpful.  

Prerequisite Friction Note: Prior deep expertise in EU MDR, US FDA 21 CFR, or CMDR regulations is not required. All core terminology and regional framework differences will be introduced during the training.  
This training is tailored for cross-functional professionals and functional groups operating within medical device and IVD organizations:  
  • Quality Assurance & Regulatory Affairs (QA/RA) 
  • Legal, Compliance & Risk Management 
  • R&D, Engineering & Technical Services 
  • Commercial, Product Management, Sales & Marketing 
  • Clinical Affairs & External Consultants.

Comprehensive Regulatory Expertise

Gain recognized certification, advance your regulatory career, and learn at your own pace with a flexible learning schedule designed for medical device professionals.
Upon successful completion of the program, participants receive a recognized certification, boosting their career prospects and demonstrating their expertise to employers and clients.

Certification and Career Advancement

We offer a flexible learning schedule, allowing professionals to balance their training with their busy work and personal lives, ensuring accessibility to a wide range of learners.

Flexible Learning Schedule

Modules

Explore the training modules available in this course

Meet the Trainer

René Schings

René, with over 20 years of management experience in Quality Management, Research & Development, and more, serves as a lead auditor at Qserve, specializing in ISO audits, and brings expertise in building QMS for start-ups, managing complex change projects, and overseeing multi-site, multi-cultural teams, having previously held senior positions in the Medical Device and Consumer Electronics industries.
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