DLC has significant experience in clinical performance studies for IVDs. Over the last five years, DLC has managed large, multi-country studies with over 5,000 subjects enrolled, as well as smaller studies, in Europe and the US. Around 30% of these studies were performed to generate data for FDA product clearance and included the preparation of 510(k) submissions to FDA.
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Element not found inIn Vitro Diagnostic (IVD) Device Clinical Areas
Clinical areas of performance studies managed by DLC include:
- Cancer detection and monitoring e.g. colorectal, breast, lung
- Sars-CoV-2 diagnosis
- Coagulation factors
- Pulmonary Embolism and Deep Vein Thrombosis
- Infectious diseases (HPV, HepB, Chlamidia trachomatis, Neisseria gonorrhoeae, Group B Streptococcus, Torch etc)
- Sepsis
- Hormone measurement
- In vitro fertilization (sperm cell selection)
Please visit the ‘Medical device therapeutic areas’ webpage for information on DLC’s clinical study experience for medical devices.
Please contact us for further information or assistance.
