Yesterday, the EU Parliament adopted the regulation amending EU 2017/745 (MDR) and EU 2017/746 (IVDR) aiming to protect patients by ensuring the availability of safe devices that are essential for healthcare systems. The amending regulation extends the transition...
2024 IVDR Sprint: 6 Reasons Why You Should Start a Performance Evaluation Early
In accordance with Article 5(3) of Regulation (EU) 2017/746 (IVDR), a performance evaluation must be drawn up for every IVD placed on the European market, regardless of the device's risk class (Yes, even class A devices require a proper performance evaluation!). As...
Webinar – 2024 IVDR Sprint Series: How to Deal with Regulatory Requirements when Collecting Clinical Performance Data
Mastering Time and Compliance How to Deal with Regulatory Requirements when Collecting Clinical Performance Data IVDR imposes stricter requirements for clinical evidence, including a higher level of scrutiny and more stringent criteria for study design,...
Preclinical Insights #37 – Prof. Alexandre Carpentier
Veranex is proud to share the latest issue of our Preclinical Insights publication. In this issue we talk with Prof. Alexandre Carpentier about his journey and work. Prof. Alexandre Carpentier, Neurosurgeon at the Pitié-Salpêtrière University Hospital (AP-HP) Prof....
Training: QMSR Transition — Preparing for FDA ISO 13485 Harmonization in the EU
Speaker: Paige Sutton-Smith, Quality and Regulatory Affairs Manager Date: June 13, 2024 Duration: 3 hours | 9:00 AM – 12:00 PM (US Eastern Standard Time), 3:00 - 6:00 PM (Central Europe Summer Time) Virtual A recording will be available to registered participants, in...
Patient-Centric and Ecosystem Insights into Hepatocellular Carcinoma across Asia-Pacific
Study by Veranex and Alcon Highlights Time Efficiencies for Femtosecond Laser-Assisted Cataract Surgery
Veranex's Commercial Strategy team partnered with Alcon in 2020 to design and execute a time-and-motion study comparing Alcon's femtosecond laser system against a competitor. The goal of this study was to compare time efficiencies between the two systems, as cataract...
Recent Study Co-Authored by Veranex to be Presented at ISPOR 2024
225,000 vitrectomy surgeries are performed annually in the U.S. A time-driven cost analysis conducted at a US academic hospital found the average true cost of routine vitrectomies (including macular hole (MH) surgeries) is $7,169.79 per patient, $2,000 above CMS’s...
Study Co-Authored by Veranex Found that Mobile Cardiac Outpatient Telemetry (MCOT) was Associated with Lower Readmissions and Healthcare Costs in Post-Stroke Monitored Patients, Compared to Implantable Loop Recorders
This study compares the health and economic outcomes of using mobile cardiac outpatient telemetry (MCOT) and implantable loop recorders (ILRs) for long-term monitoring following an inpatient visit in patients who have had a stroke by analyzing Optum’s de-identified...
Training: European Database for Medical Devices (EUDAMED)
Speaker: Somashekara Koushik Ayalasomayajula, Quality and Regulatory Affairs Director Date: June 18th 2024, Online Duration: 4 hours | 7:30 – 11:30 AM (EDT), 1:30 PM – 5:30 PM (CEST) About the Speaker: Somashekara Koushik Ayalasomayajula is a polymer engineer and an...