Thursday, September 07, 2023
VentureMed Group, Inc., a privately-held pioneer in the field of medical devices specializing in access management for arteriovenous (AV) fistulas and grafts, as well as vessel preparation for interventional treatment of peripheral arterial disease (PAD), is pleased to announce its early reception of the MDR certification. This certification signifies that the FLEX device fully adheres to the specified requirements and conformity assessment procedures necessary for the introduction of medical devices into the European Economic Area.
Jill Schweiger, Vice President of Clinical, Regulatory, and Quality at VentureMed, highlighted, "CE Mark conformity under these updated requirements places an increased emphasis on both quality and patient safety, underscoring our unwavering commitment to providing the safest and highest-quality products for our valued customers and their patients."
Denis Harrington, President and CEO of VentureMed, added, "Achieving MDR certification underscores our resolute dedication to quality and streamlines the ongoing expansion of the FLEX Vessel Prep System into CE-marked territories."