MedTech
Expertise: Medical Device 36 results
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...
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...
CE marking is mandatory for marketing medical devices and in vitro diagnostics (IVDs) in the European single market, comprising all European Union (EU) member states and European Economic Area (EEA) countries. With the introduction of the EU Medical Devices Regulation...
Medical Device
5 Stages of Medical Device Development
Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to...