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Expertise

Kory Dillman​

Associate Director, ​ Global Regulatory Affairs​

Expertise:

Digital Technology, Regulatory, Regulatory Compliance

Kory is a Regulatory Affairs Associate Director with extensive experience in Software as a Medical Device and Software Development Life Cycle.

Kory has 20+ years of experience in business and technology operations and 9 years of experience in Regulatory Affairs at companies of varying sizes and industries.

Kory has authored and managed submissions for global markets including Australia, Brazil, Canada, EU, Malaysia, Saudi Arabia, and the United States. His other areas of expertise include Quality Systems, Business Process Management, Program Management, and Business Development.

 

Articles by Kory Dillman​

FDA Moves Cybersecurity Into the Product Life Cycle

Due to rising cyber-attacks and the potential to cause harm to patients, medical facilities and hospitals, the U.S. Food and Drug Administration (FDA) has recently increased scrutiny of cyber controls in FDA premarket submissions of medical devices. Manufacturers must prove that devices, including software-as-a-medical device (SaMD), do not present cybersecurity vulnerabilities that may affect the […]

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