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From Change to Clearance: Leveraging Predetermined Change Control Plans to Accelerate Regulatory Approvals and Innovation
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Hemang Kotecha, MS, RAC – Medtronic ### 2812004###Presenter###Sr. Principal Regulatory Affairs Specialist###Medtronic###
Presenter: Hemang Kotecha, MS, RAC – Medtronic
###
From Insight to Impact: A Practical Guide to Reviewing and Shaping Regulatory Guidance
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Jonali N. Ramani, RAC – organon ### 2812080###Presenter###Sr. Manager Regulatory Affairs###organon###
Presenter: Jonali N. Ramani, RAC – organon
###
From Nonconformities to Insight: Leveraging Biocompatibility Assessment Trends for Regulatory Intelligence and Strategic Compliance
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Shahriar Sharifi, PhD – Gmed Nort America ### 2812079###Presenter###Medical device expert and biocompatibility SME###Gmed Nort America###
Presenter: Shahriar Sharifi, PhD – Gmed Nort America
###
From Risk to Readiness: Lessons Learned in Medical Device Cybersecurity Documentation for FDA Submissions
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Michelle Lynn Jump, MS – MedSec ### 535528###Presenter###CEO###MedSec###
Presenter: Michelle Lynn Jump, MS – MedSec
###