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Risk Communication of Medical Device Failures

  • Training

  • 60 Minutes
  • Compliance Online
  • ID: 5975902
This Risk communication webinar/training 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.

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

Course Provider

  • Marta L Villarraga
  • Marta L Villarraga,