Conference Description:

Description

Failure Mode and Effect Analysis can be used to assess the efficacy and efficiency of the device in actual use. Failure Mode Effects Analysis (FMEA) can have a number of variations the aim is to thoroughly review what can go wrong in use and what kind of misuses may be made. The device manufacturer must consider how to protect patients in case of misuse of the device such as ventilators and PCA pumps for pain control. Many patients have died from its inadvertent misuse. It is also important to consider processes such as packaging, sterilization, shipping of wrong kits, and labeling. These have many risks associated with them that could adversely affect the performance of the device.

Course Objective

The legal system, the FDA, and the European standards require the device to be safe as long as it is in use. Therefore high reliability is an obvious requirement. Besides, it is a value proposition for the business: zero warranty costs, safe customers, more loyal customers, and more sales. The FDA reviews the results of the risk analysis during pre-market approvals, and FMEA is the most thorough document risk analysis, design control, and device history. Therefore a thorough understanding of FMEA for designing device for reliable and safe performance is a critical marketing strategy.

Course Outline

How FMEAs are usually misused in medical devices
How to get most value from FMEAs
The correct way to conduct FMEA
How to get users involved in the FMEA
How to integrate FMEA in the risk management process
Eliminating design defects to reduce risks of recall
Eliminating manufacturing defects to reduce risk of recall
Eliminating maintenance mistakes using FMEA
New heuristics for getting fast results

Target Audience

Senior management
Entire engineering staff
All technical managers
Test engineering staff
Regulatory affairs professionals
Marketing Managers
Service managers
Project Managers and engineers
Quality Assurance staff
IT professionals looking to make the design process efficient


Speaker: Dev R.,
Dev, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare,medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation.

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