Donawa Lifescience is actively working with in vitro diagnostic (IVD) medical device companies seeking to achieve the CE mark for COVID-19 diagnostic kits.
We have most recently assisted a company in obtaining ethics committee approval for a clinical study of a new IVD to detect SARs Cov-2. The study will take place in the north of Italy. We are also helping companies develop their Technical Files for compliance with CE marking requirements for other IVDs for COVID-19 detection.
Some of our clients are also seeking support for entering the US market under the 510(k) program or the recently introduced Emergency Use Authorization (EUA) program for IVDs and other medical devices.
Donawa Lifescience also provides comprehensive support to companies in the design and conduct clinical studies that may be required to achieve these and other objectives. Please get in touch via firstname.lastname@example.org to discuss your requirements.