MedTech
Expertise: MedTech 28 results
MedTech
OCT Med Device (EU)
MedTech
SCOPE US
Post-market clinical follow-up (PMCF) activities are necessary for continuously monitoring the clinical benefits, performance, and safety of medical devices after they have been released on the market. As part of a broader post-market surveillance (PMS) strategy, these activities are crucial...
In vitro diagnostics (IVDs) have become a cornerstone of modern medicine, and rising demand for these critical medical devices has driven rapid market growth. Since 2021, hospitals and laboratories have demonstrated an increasing preference for point-of-care testing devices to get...
The quest to maintain the appearance of youth has fueled widespread use of injectable dermal fillers—and a deeply competitive landscape. A host of approved products are readily available in the United States, used to ameliorate nasolabial folds, perioral lines, lips,...
Diagnostic research encompasses a wide array of tools, including medical devices, imaging techniques, and laboratory tests, all aimed at assessing the accuracy, safety, and effectiveness of diagnosing diseases or conditions. The primary endpoints in diagnostic trials typically test accuracy metrics...
Under the EU Medical Device Regulation (MDR), manufacturers are required to plan, conduct, and document a clinical evaluation in accordance with Article 61, part A of Annex XI.