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Wednesday, August 20, 2014
10:00 PM - 11:00 AM
10:00 PM - 11:00 AM See all dates and Times
http://complianzworld.com/Webinars.aspx?TopicId=495&Sub=Designing-Medical-Devices-for-Long-Life-at-Lower-Costs
Description: Seemingly harmless structural components, such as a humidifier lid hinge of a CPAP (continuous positive airway pressure) machine, might be strong enough to withstand a single applied load or a few open/close cycles. But what happens when the lid operates over and over, opening and closing, day after day, for years? Predicting component failure in such cases requires what's called fatigue or durability analysis. Computer simulations can help but the device has to be tested for durability using accelerated life tests. Results are important in calculating the minimum life and assuring that the part meets the life cycle duty requirements under extreme usage conditions. In case of critical care devices such as heart implantable devices that cannot be repaired easily, it is crucial to ensure that the moving parts that perform cyclic motions are extremely durable.
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 durability is an obvious requirement. Besides, it is a value proposition for the business: zero warranty costs, more loyal customers, and more sales.
Course Outline:
Durability is the major reason for FDA device recalls
Frequent mistakes in the design process
Principles of long life design
Which portions of the device to design for long life
System Functions FMEA to identify weakest links
Pre-Market Durability Review
Principles of designing at low cost or no cost
Examples of low or no cost improvements
Validating for long life
Designing a life test
Life prediction models
Pre-Market Durability Review
Management responsibility
Target Audience:
Vice Presidents of Engineering, Servicing, and Marketing
Hardware Engineers and Managers
Software Engineers and Managers
System Engineers
Quality Engineering staff
Quality Auditors
Medical staff evaluating risk, safety or effectiveness
Quality or regulatory staff assigned to complaint, CAPA or MDR management
Marketing Managers
Service staff
Device Users
Corporate counsels
Webinar Price Tags :
$ 229.00 Single Attendee
$ 749.00 Group Max 10 Attendees per location
$ 269.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
For Further Information Or Registration :
phone : +1-866-978-0800
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 durability is an obvious requirement. Besides, it is a value proposition for the business: zero warranty costs, more loyal customers, and more sales.
Course Outline:
Durability is the major reason for FDA device recalls
Frequent mistakes in the design process
Principles of long life design
Which portions of the device to design for long life
System Functions FMEA to identify weakest links
Pre-Market Durability Review
Principles of designing at low cost or no cost
Examples of low or no cost improvements
Validating for long life
Designing a life test
Life prediction models
Pre-Market Durability Review
Management responsibility
Target Audience:
Vice Presidents of Engineering, Servicing, and Marketing
Hardware Engineers and Managers
Software Engineers and Managers
System Engineers
Quality Engineering staff
Quality Auditors
Medical staff evaluating risk, safety or effectiveness
Quality or regulatory staff assigned to complaint, CAPA or MDR management
Marketing Managers
Service staff
Device Users
Corporate counsels
Webinar Price Tags :
$ 229.00 Single Attendee
$ 749.00 Group Max 10 Attendees per location
$ 269.00 Access Recorded Version online
$ 399.00 Buy Training CD-DVD
For Further Information Or Registration :
phone : +1-866-978-0800
