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Maria Donawa to speak at the 8th EAAR Annual Conference on 26-27 February 2024

The 8th EAAR Annual Conference on New Medical Device Regulations (RMD2024) will take place in Brussels, Belgium, on 26-27 February 2024, featuring speakers from across the MedTech industry, including regulators and notified bodies. Organized by the European Association of Authorised Representatives (EAAR), the conference serves as an inclusive platform for all stakeholders across the both medical…

20 October 2023
Donawa Lifescience personnel to speak at CTRMD2023 Conference

Donawa Lifescience VP Operations and Clinical Affairs, Daniela Karrer, and Director, Clinical Affairs, are both scheduled to deliver papers at The American Conference on Clinical Trials and Regulation of Medical Devices, taking place in Orlando, Florida, USA, from 20 to 21 November 2023. The conference is intended to be of special interest to regulatory affairs,…

3 October 2023
Maria Donawa presented on EU/US differences at Vienna Conference on Clinical Studies

Donawa Lifescience President, Maria E. Donawa M.D., spoke at the ​2nd Conference on Clinical Studies with Medical Devices and IVDs, which took place in Vienna, Austria, on 30-31 March 2023. This year’s conference was designed to provide a wealth of information for both medical device and in vitro diagnostic clinical investigations, with a particular focus…

18 June 2023
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