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.

8th Semi-Annual Risk Based Medical Device Supplier Quality Assurance Conference

Dennis Gucciardo is speaking on steps required to document supplier risk assessment in alignment with ISO at the 8th Semi-Annual Risk Based Medical Device Supplier Quality Assurance...

MDMA Annual Meeting

Beth Roberts will moderate the panel "Accelerating Patient Access to Technology" at the Medical Device Manufacturers Association (MDMA) Annual Meeting. The panel will discuss what the...

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