Online CourseOnline Course Medical Device Certificate ElectiveMedical Device Certificate Elective

Medical Devices: Corrections, Removals and Directed Recalls [6.0 RAC]

6.0 RAC Credits Member: $570.00 Nonmember: $790.00
Medical Devices: Corrections, Removals and Directed Recalls [6.0 RAC]
Medical device recalls are a difficult aspect for medical device manufacturers and distributors, and most importantly, with the end users of these devices. Balancing the needs of the users along with the various regulatory requirements creates challenges for those responsible for deciding and executing recalls. A medical device recall does not always mean that you must stop using the product or return it to the company. It sometimes means that the medical device needs to be checked, adjusted, fixed or provided with additional labeling to ensure the safe and effective use of the product.

This course examines compliance with US FDA, Health Canada, and European Union requirements and regulations. The definitions of the recall classification and type are explained together with the importance of the recall strategy, planning, communication, reporting and record keeping. The value of knowing the FDA 21 CFR requirements (including §7, §806, and §810), Canadian Medical Device Regulations (CMDR) and guidance and European medical devices directives (MDD, AIMDD and IVDD; and MEDDEV guidance) is explained in detail.

At a Glance
  • Target Audience: This course is intended for the following functional groups and personnel in a medical device organization: regulatory affairs, quality assurance, legal, compliance management, engineering and technical services, commercial and product managers, sales and marketing, risk management, clinical affairs and consultants
  • Learning Level: Basic, Intermediate
  • Total Length of Course: 6 Hours
  • RAC Points: 6

Learning Objectives

Upon completion of this course, participants should be able to:
  • Determine what actions are taken in a medical device recall
  • Cite the regulatory requirements for recalls/ field actions regarding medical devices
  • Reference and use medical device recall authority and guidance documents
  • Identify and understand the applicable regulatory standards and guidance documents
  • Discuss what is required for the recall strategy as expected by Health Authorities
  • Identify the different recall types and classifications
  • Explain what types of communications are required
  • Define what effectiveness checks are
  • Outline the steps required to terminate a recall and what regulatory reports and records are required for a device recall

Lesson Titles
  • Lesson 1: Regulations Pertaining to Corrections, Removals and Directed Recalls
  • Lesson 2: Identifying an Issue
  • Lesson 3: Escalation
  • Lesson 4: Recall Planning
  • Lesson 5: Recall Execution
  • Lesson 6: Recall Closure

Enrollment Period: 12 months
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