VentureMed Group Receives European Medical Device Regulation (MDR) Certification for FLEX Vessel Prep™ System
MINNEAPOLIS, Sept. 6, 2023 /PRNewswire/ -- VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification.
- MINNEAPOLIS, Sept. 6, 2023 /PRNewswire/ -- VentureMed Group, Inc., a privately held medical device innovator in access management for arteriovenous (AV) fistulas and grafts and vessel preparation for interventional treatment of peripheral arterial disease (PAD) announced today that the company is an early recipient of MDR certification.
- Gaining MDR certification ensures the FLEX device is in alignment with described requirements and conformity assessment procedures that must be met before medical devices are introduced into the European Economic Area.
- "CE Mark under these new requirements is more stringent than the CE Mark under the Medical Device Directive and is focused on quality as well as patient safety.
- "MDR certification demonstrates our commitment to quality and will enable continued commercial expansion of the FLEX Vessel Prep System into the CE marked geographies."