Notified bodies use a clinical evaluation assessment report (CEAR) to clearly document the conclusions of its assessment of the clinical evidence presented by medical device manufacturers in clinical evaluation reports (CERs) and associated documentation. The assessment of clinical evidence is a core requirement of the Medical Device Regulation (MDR, 2017/745). Use of a harmonised CEAR…
Donawa Lifescience is pleased to inform its clients that in relation to travel restrictions during the coronavirus pandemic, our Clinical Department has implemented an efficient procedure for remote monitoring visits. European harmonized standards for clinical studies with medical devices or in vitro diagnostics, as well as the US Food and Drug Administration allow and, in…
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…
We would like to advise clients that the Donawa team in our Rome office is fully operational. We have implemented a fast smart-work connection that allows employees to work from home, should this be necessary, although the office will remain open as some of us live close. With regard to associates who work on projects…
Donawa Lifescience will again be participating in the 2020 RAPS Euro Convergence Conference, now being held in Brussels from 26-28 October 2020. Donawa Lifescience will be involved in two conference sessions, the first conference session specifically dedicated to In Vitro Diagnostic Devices, in which Donawa’s President, Maria E. Donawa, M.D., will chair the session, titled…
The “European Conference on Clinical Studies with Medical Devices and IVDs” (CSMD2020) will take place on 16-17 November 2020 in Vienna, Austria. The Conference is designed to address the most challenging and perplexing aspects of planning and conducting medical device and IVD clinical studies in accordance with the requirements of the European Medical Device Regulation…
Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a wholly owned company in the US State of Massachusetts, Donawa Lifescience Inc., to promote its Clinical Research Organisation activities to both its existing and potential North American clients. Donawa Lifescience Inc., together with…
