top of page

Quality & Regulation Track

PMCF Strategy for Successful Clinical Evidence

PMCF Strategy for Successful Clinical Evidence

Ronit Haviv web.jpg

Dr. Naida Gurshumov, PhD

Clinical Consultant, HaMaDa Consultants‎

DOWNLOAD
Brazil Carnival Experience – The Regulatory Clearance of the Pulsenmore ES in Brazil

Brazil Carnival Experience – The Regulatory Clearance of the Pulsenmore ES in Brazil

Ronit Haviv web.jpg

Israel A. Citron MBA, MSc.

VP Regulatory Affairs and Quality Assurance, Pulsenmore

DOWNLOAD
Change The Study Protocol To Rescue A Trial - When/Why/Challenges

Change The Study Protocol To Rescue A Trial - When/Why/Challenges

Ronit Haviv web.jpg

Dr. Ronit Haviv, PhD

SrVP Clinical and Regulation Affairs, Cordio Medical

DOWNLOAD
How to CYBER a Product for FDA

How to CYBER a Product for FDA

Ronit Haviv web.jpg

Daniel Kleinberg

QARA Cyber Expert, Matrix Medika

DOWNLOAD
The FDA & EU Artificial Intelligence Directive and the Implication for Medical Device Manufacturers - New and Coming Standards for AI/ML in Medical Devices

The FDA & EU Artificial Intelligence Directive and the Implication for Medical Device Manufacturers - New and Coming Standards for AI/ML in Medical Devices

Ronit Haviv web.jpg

Dina Sifri

Founder and CEO, MedDev Soft

DOWNLOAD
How FDA’s New eSTAR Requirement is Affecting Industry

How FDA’s New eSTAR Requirement is Affecting Industry

Ronit Haviv web.jpg

Michael (Moshe) Kasser

Senior Director of Regulatory Strategy, Hogan Lovells

DOWNLOAD
bottom of page