Veristat
Veristat is a full-service clinical research organization.
When is a Clinical Investigation required for a Medical Device?
“Under MDR, Class III and implantable Medical Devices generally require a Clinical Investigation to evaluate safety and performance, though exceptions can apply depending on the specific device and its regulatory pathway.”
在公司资料中查看What's the difference between a Performance Evaluation Report and a Performance Study for an IVD?
“A Performance Evaluation Report (PER) assesses existing data, including literature and equivalent device data, to establish an IVD's scientific validity and performance, while a Performance Study is a study specifically designed to confirm the IVD's analytical or clinical performance for its intended purpose.”
在公司资料中查看What does a regulatory gap analysis identify for a MD or IVD program?
“A regulatory Gap Analysis identifies the difference between a device's current state of development and what's required for certification, helping define the objectives and milestones needed to reach the next goal, whether that's entering clinical stage, completing clinical evaluation, or obtaining the CE mark.”
在公司资料中查看What is the CE mark, and how does it compare to FDA approval?
“The CE mark is the certification required to legally market a medical device or IVD in the European Economic Area (EEA), similar in purpose to FDA clearance or approval in the US, though the two follow entirely different regulatory pathways and requirements.”
在公司资料中查看