Sydney: Join leaders from Hogan Lovells Medical Device team for conversation and cocktails

We welcome you to join members of our medical device and health care regulatory team as we discuss how to navigate the shifting regulatory landscape facing medical device firms. From...

9th Annual Medical Device Supplier Quality Assurance Conference

Dennis Gucciardo addressed the regulatory clarification on risk assessment within the ISO 13485:2016 framework at the 9th Annual Medical Device Supplier Quality Assurance Conference.

Modifications to 510(k) - Cleared devices: Assessing the impact of FDA's 2017 final guidance documents

On December 6, Danielle Humphrey and Kristin Zielinski Duggan led a complimentary webinar, which covered:

FDLI Introduction to Medical Device Law and Regulation

On November 7, 2018 Danielle Humphrey presented a session titled "Clinical Investigations: Investigational Device Exemption (IDE), Institutional Review Boards (IRBs), and Informed Consent"...

9th Annual Advertising and Promotion of Medical Devices Conference

On November 6, 2018, Danielle Humphrey presented a session on Medical Device Enforcement and Compliance at the AdvaMed Advertising and Promotion of Medical Devices Conference.

Master Class: Medical Device Clinical Research: The Path From Concept to Approval (Part 2)

Lina Kontos spoke in the Master Class: Medical Device Clinical Research: The Path From Concept to Approval (Part 2) session at the Magi's Clinical Research Conference - 2018 West on Sunday, ...

510(k) Submissions Workshop – Fall 2018

On October 16, 2018, Danielle Humphrey led an Advanced Medical Technology Association (AdvaMed) workshop titled "510(k) Post-Clearance Process."

The MedTech Conference

Danielle Humphrey presented on Food and Drug Administration (FDA) regulation of adaptive medicine at the Australian Pavilion during The MedTech Conference.

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