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Tuesday, April 10 • 3:30pm - 5:00pm
Session J - Roundtables Track

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J-1   Medical Device Test Article Characterization - Sponsor and CRO Perspective 

Medical devices run the gamut from single materials to composite materials, may include different functional components, be combination products, electronic devices, and may have associated software.  With all this variation, how do you meet the requirements of §58.105, clearly identify what is being tested and have sufficient documentation to prove it.  This session will present best practices to achieve compliance for test article characterization for the various types of medical devices that are currently available.  Best practices will be discussed from the perspective of the CRO and sponsor.

Medical Device

Level of Content:

avatar for Debra Bridges

Debra Bridges

GLP Consulting Services
Debra Bridges is President of GLP Consulting Services and former Associate Director of Operations and Regulatory Compliance for the Texas A&M Institute for Preclinical Studies. She has over 25 years of quality assurance, regulatory compliance, and combined research experience in industry... Read More →

avatar for Hector Gamboa

Hector Gamboa

Sr. Quality Audit Specialist, Abbott
Hector Gamboa is Registered Quality Assurance Professional in Good Laboratory Practices (RQAP-GLP). He was the 2016 President of the Pacific Regional Chapter of the SQA (PRCSQA) and he currently serves as a member of the Board of Directors at the Society of Quality Assurance (SQA... Read More →

Felice Randi LaMadeleine

Manager - Quality Assurance, Toxikon Corporation
Ms. LaMadeleine has over 25 years of experience in the medical device, pharmaceutical, industrial chemistry, and biotech industry, with the last 16 years in Quality Assurance. She joined Toxikon Corporation as a Data Reviewer/Auditor in 2000, then became a Quality Assurance Officer... Read More →

Tuesday April 10, 2018 3:30pm - 5:00pm PDT
Platinum 9&10