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Design Controls: A Deep Dive into Verification vs. Validation

Thursday, June 15
10:15 am – 12:15 pm
Room 49

Related Resources:
Pareto Analysis: Tools for New Product Testing
Design Intent: Do I Need to Perform Verification and Validation?
When Do I See a CAPA Specialist?


Denise Dion

Vice President, Regulatory and Quality Service




Design Controls can be a valuable tool in device design, but orthopaedic device professionals continue to struggle with the differences between verification and validation. 
This two-hour session will review ways that Design Controls can be made useful through V&V's proper use. Further, it will highlight actions you should take now in order to successfully transition to the updated standard. 


Attendee Takeaways

  1. The differences between verification and validation
  2. Specific examples of ways that verification and validation work within product design
  3. How Design Controls can be made useful to device design and your business


Ms. Dion is Vice President, Regulatory and Quality Services for EduQuest and has been with the company since December 2002. She left the Food and Drug Administration (FDA) in 2002 after 18 years. During her last eight years with FDA, she served in FDA headquarters as the medical device investigator liaison between the Office of Regulatory Affairs (ORA) and the Center for Devices and Radiological Health, as well as between ORA headquarters and field staff. Ms. Dion was one of the designers, authors and trainers for the Quality System Inspection Technique and training materials. She served on FDA’s Design Control Inspection Strategy Team, was the editor of the Investigations Operations Manual for five years and participated in FDA’s basic medical device and process validation training.

Helpful links: Synergetic Dissimilarity: Design Validation/Verification and Process Validation | 8 Design Control Issues Found During FDA Inspections