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Articles written by Denise Dion

Risk Assessments: How Often Should I Update Them?

by Denise Dion | Oct 2017

Denise Dion from EduQuest provides advice on when to update your risk documentation. ... Read more »

Proving Your New Design is Production Equivalent

by Denise Dion | Jun 2017

Design validation is essential to new product development, especially when using multiple suppliers to manufacture your device. Our experts weigh in on how to determine your product is production equivalent. ... Read more »

When Do I See a CAPA Specialist?

by Denise Dion | May 2017

If your company struggles with deciding when to elevate a complaint to the level of a CAPA, how do we differentiate between complaints, non-conformances and CAPAs? Our experts respond. ... Read more »

Design Intent: Do I Need to Perform Verification and Validation?

by Denise Dion | Apr 2017

If you’ve characterized a material change to your medical device and confirmed no impact to any of your design inputs or outputs, do you have to formally perform verification and validation? Our experts respond. ... Read more »