Risk Communication of Medical Device Failures

Risk communication of medical device failures can take place at both the development (pre-marketing) and post-development (post-marketing) stages of any medical device. Identifying medical device failures and communicating these findings are essential components during both stages. Effective risk communication of medical device failures provides manufacturers with the appropriate information to make decisions regarding the risks to health, patients, and overall safety. It also provides the public (end-users and patients) with increased knowledge on the performance of medical devices, their use in medical procedures and the potentials for malfunction, misuse, or hazards.

Areas Covered in the seminar:

• Why is risk communication important?
• What is the role of risk communication within risk management?
• How risk communication is different before and after a product has been released to the market?
• What is important in risk communication before the product has been released to the market?
• What is the role of risk communication after the product has been released to the market?

Who will benefit:

This presentation will review the types of risk communications that take place regarding medical device failures at both pre- and post-marketing stages in the lifecycle of medical devices. The employees who will benefit include:

• Engineering staff in design and manufacturing
• Health professionals who interface with physician or patient users
• QA managers and personnel
• Regulatory Affairs managers and personnel

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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