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Company News

Donawa Lifescience project continuity during Covid-19 Italian restrictions

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…

March 20, 2020
Donawa participating in RAPS 2020 Euro Convergence Conference

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…

March 20, 2020
Maria Donawa to chair Vienna Conference on Clinical Studies with Medical Devices and IVDs

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…

March 4, 2020
Donawa Lifescience Consulting announces opening of CRO office in United States

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…

October 25, 2019
Avoiding delays when conducting medical device clinical or IVD performance evaluation studies in Germany

Germany is a sought-after location for conducting medical device clinical studies and in vitro diagnostic (IVD) performance evaluation studies. This article discusses certain aspects of conducting such studies in Germany, which if not clearly understood, can lead to unnecessary and costly delays.

May 15, 2019
Updated regulations on FDA acceptance of medical device clinical data in effect soon

On February 2018, FDA published a final rule updating its regulations on the acceptance of clinical data generated outside or inside the US, which are intended to support any type of medical device FDA application or submission. A previous article discussed the proposed rule. This article will provide an overview of the updated regulations…

February 25, 2019
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