An Introduction to HIPAA & GDPR Compliance
for Medical Device & IVD
August 7, 2019
College Hill Library, Front Range Community College
3:30 – 4:00 Registration and networking
4:00 – 5:00 Presentation
RMRAS is pleased to have Caitlyn Chavira, Senior RAQA Consultant, with Evergreen Research as our August 2019 presenter.
This presentation will summarize the history, requirements and potential pathways for complying with the requirements of HIPAA and EU GDPR in the
Ms. Chavira has just under a decade of experience as a quality and regulatory professional with diverse product portfolio experience in the regulated medical devices industry. With a background in quality systems and software quality engineering, and experience managing multi-location quality system organizations, Ms. Chavira has had critical impact on developing and bringing device innovation to markets in US, EU, Australia and China, and additionally maintaining established compliance in Japan, Brazil and Canada. She has assisted organizations in achieving successful ISO 13485:2016 certification, MDSAP certification, FDA breakthrough device designation and CE marking. Ms. Chavira has experience in risk management and assessment, quality systems program management, sterilization validation and process monitoring, bioburden analysis, product project management, international standards and regulation gap analysis, software classification and validation, GDPR assessment and compliance, materials compliance and is versed in general manufacturing engineering principals. She is also certified trained in MDR transition for CE marked devices in the EU.
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Front Range Community College
Room L-211, College Hill Library
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