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Company News

Donawa Lifescience opens GB company to provide UKRP services

Donawa Lifescience Consulting (DLC), headquartered in Rome, Italy, has announced the opening of a company in Great Britain (GB), Donawa Lifescience Ltd., to provide non-UK companies with ‘United Kingdom Responsible Person’ (UKRP) services as an easy initial pathway to the post-Brexit medical device market in Great Britain. Following the publication of the UK Medicines and…

23 October 2020
Maria Donawa authors new White Paper for BSI Compliance Navigator

Donawa Lifescience President, Maria E. Donawa M.D., has authored a new White Paper for inclusion in BSI’s Compliance Navigator series, titled ‘Medical device clinical investigations – What’s new under the MDR?’ The 30 page document discusses the important new requirements for pre-market and post-market clinical investigations included in the European Medical Device Regulation (MDR, 2017/745),…

15 September 2020
Donawa Lifescience using remote monitoring during coronavirus pandemic

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…

7 May 2020
Donawa Lifescience helping clients gain approval for COVID-19 diagnostic studies

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…

24 April 2020
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…

20 March 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…

20 March 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…

4 March 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…

25 October 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.

15 May 2019
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