Expertise: Medical Device 45 results
MedTech
OCT Med Device (EU)
MedTech
SCOPE US
In today’s competitive landscape, device companies are facing increased demand for clinical evidence of product efficacy and safety. In addition to pressure from regulators prior to market approval, device companies must answer to other stakeholders, including: Payers who are requiring...
On April 29, 2024, the U.S. Food and Drug Administration (FDA) announced a final rule that was initially proposed in September 2023 concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount...
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.
Metabolic
Milena Kanova-Petrova, M.D.
As a sponsor wisely noted, “Clinical trials have nothing without participants.” Yet, in a 2023 study, 48% of sites cited patient recruitment and enrollment as a top challenge. The downstream impacts of recruitment challenges are profound for sponsors, sites, and...