Justin O’Neal
Quality Director Compliance Services
Expertise:
Justin is a Quality Assurance Director with extensive Quality experience in quality strategy, product development, and life-cycle management of medical devices and combination products.
He has 11+ years of quality and contract manufacturing experience which includes responsibilities from research and development to post-market with a significant number of small start-up to Fortune 500 companies within the medical device, biologics, and pharmaceutical industries. Justin is experienced in compliance and compliance remediation, as well as working with R&D, regulatory, marketing, sales, legal, operations, manufacturing, and supply chain organizations.
Articles by Justin O’Neal
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 device’s safety, effectiveness or security. The FDA recently summarized the significance of the situation, stating, “Cybersecurity incidents have rendered medical devices and hospital networks inoperable, disrupting the delivery of patient care across healthcare facilities in the US and globally.” Both Congress and the FDA recently introduced actions addressing the problem. The bipartisan PATCH Act (Protecting […]