Online Training 2015 - Designing Medical Devices for Long Life at Lower Costs - By Compliance Global Inc

Overview
The number of medical device recalls was up 28% in 2013 and estimated to be even higher in 2014. Learning to design for durability using risk analysis tools the right way at right time can eliminate many life cycle costs such as production rejects, rework, warranty costs, safety litigation costs, and maintenance and repair costs to customers. Learn how to design it right the first time for not only long life design but understand that no safety related failures should occur during the long life.
Why Should You Attend
A critical and sometimes overlooked aspect of medical device design is the inability to implement systems thinking. Usually the specifications are flawed, designs are flawed, manufacturing requirements for defect-free production are flawed, and integration among users, suppliers, and interfaces is flawed.
Systems thinking is not a panacea that can prevent every mistake, but it a best known tool that helps us design for zero failures for a long time and help us see many robust solutions to eliminate risks including warranty costs. Unlike the limited single focused cause-and-effect approach, the systems thinking is about relatedness of individual causes to system causes, interdependencies on the knowledge of cross functional teams, interdependencies on the knowledge of manufacturers and device users, and understanding what you don’t know about device durability.
Areas Covered in this Webinar
Introduction to medical device quality requirements
Writing specifications for long life free of failures
Correctly using risk assessment
Risk mitigation plan for long life
Avoiding mistakes during early design
Using system functions fmea
Learning Objectives
Failure analysis to prevent adverse events
Verifications during the detail design
Preventing manufacturing defects by design using design validation for long life
Post production monitoring the risk to patients
Who Will Benefit
R & D Managers
Engineering Managers and Developers
Software Specialists
System Engineers
Regulatory Staff
Quality Engineers
Quality Auditors
Marketing Staff
Maintenance and Servicing Staff
Device Users
Level:
Beginner
For more detail please click on this below link:
https://complianceglobal.us/product/700241
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