American Society of Quality Dinner Forum 

Speaker Topic: "Design Quality for Medical Devices and Diagnostics"

To ensure that good quality assurance practices are used for the design of medical devices and diagnostics, design control system provides a framework for manufacturers to use and comply. Design controls designates the application of a formal methodology to the conduct of product development activities. At a high level, the US and EU regulations require:

1. Establishment of an intended use and design inputs
2. A design plan
3. Periodic design reviews throughout the design process
4. Confirmation that the design outputs conform to the design inputs through:
   • Design verification ("did we design the device right?")
   • Design validation ("did we design the right device?")
5. Translation of the design into manufacturable specifications
6. Clear documentation of the entire process in a design history file or DHF.

The objective of Design Controls, in this context, is to require that manufacturers follow a methodologically-sound process to develop a medical device, with the intent of improving the probability that the device will reach an acceptable level of efficacy and safety.

Indu Lakshman, Vice President, Quality and Regulatory, Biolmagene

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• 5:00 - 5:30 - Check In & Registration
• 5:30 - 6:10 - Networking
• 6:15 - 6:55 - Dinner
• 6:55 - 7:10 - Section Business: Section Chair,
• 7:10 - 8:25 - Presentation  
  
• 8:25 - 8:30 - Door Prize drawing

Registration- a three part process:1) having a meal? and 2) select meal if you are having one  3) pay for the meal via PayPal

• Advance $35
• Late/Walk-in $40
• Unemployed $20
• Presentation only and special guests $0

Note: Advance registration ends at midnight Monday, May 15.

Cancellation Policy: no refunds will be available unless you notify us before Monday night at midnight.

The ASQ Silicon Valley Leadership Team hopes to see you all at our dinner meeting!