Medical Device Recalls: Being Ready

Instructor: Marta L Villarraga
Product ID: 700448
Training Level: Advanced
  • Duration: 60 Min
This Medical device recall training will provide an overview on how to establish proactive practices to determine if, when you launch your medical device, you are also recall ready, explore the impact of managing the decision-making process of recall


Recalls can be very disruptive to a company, but preparation in advance can make a significant difference in minimizing this disruption.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jun-2007

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367


Read Frequently Asked Questions

Well-managed recalls are not usually "an accident," but rather the result of extensive preparation ahead of time and assembling a "recall team" with all the right capabilities and experience. Establishing and implementing adequate risk management practices for a recall is imperative given that one can happen at any time during the life cycle of a marketed product. This presentation will provide an overview on how to establish proactive practices to determine if, when you launch your medical device, you are also "recall ready," and will explore the impact of managing the decision-making process of a recall if you ever have to face one.

Areas Covered in the seminar:

  • What is a medical device recall? Review of classifcation
  • How many class I recalls have occurred over the last 3 years
  • Types of reasons for class I recalls over the last 3 years
  • Conducting the recall: what is FDA looking for?
  • The importance of a health hazard evaluation
  • Evaluating and terminating a recall
  • Preparing for a recall
  • The role of risk management in being ready for a recall

Who will benefit:

This webinar will provide insight on medical device recalls, why they have happened and how to have a good plan in place in the event one were to happen in your firm. Companies who will benefit are from the medical device and combination product fields. The employees who will benefit include:

  • QA managers and personnel
  • Regulatory Affairs managers and personnel
  • Consultants
  • Engineering staff (design and manufacturing)

Instructor Profile:

Marta L. Villarraga, Ph.D. is a Principal Engineer at Exponent, Inc, a scientific and engineering consulting firm. Dr. Villarraga concentrates her practice in failure analysis of medical devices in the areas of product liability, intellectual property, regulatory compliance, quality control and manufacturing compliance. She has assisted companies with root cause analyses prior to a recall or as part of the investigation following a recall being announced. Dr. Villarraga is also a reviewer for various scientific journals. She has also published a number of scientific articles and frequently presents at national conferences. She recently contributed to various chapters in the book "Bringing your Medical Device to Market," including one on medical device recalls. She also holds adjunct faculty appointments at various local and regional universities where she often lectures.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

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