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COMPANY NEWS

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…

DONAWA PARTICIPATING IN RAPS 2020 EUROCONVERGENCE CONFERENCE

Donawa Lifescience will again be participating in the 2020 RAPS Euroconvergence Conference, being held in Brussels from 11 to 13 May 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…

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…

Global News

Three more NBs announced for MDR

During the last month, three more notified bodies have been added to the NANDO listing for the Medical Device Regulation (MDR, 2017/745), these being: DNV GL Presafe AS (NB#2460) Norway on 6 February 2020; National Standards Authority of Ireland (NSAI) (NB#0050) on 13 February 2020; and DEKRA Certification B.V., (NB#0344) Netherlands on 6 March 2020….

MHRA shelters orphaned manufacturers

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has moved to offer a degree of protection for companies whose situation has been compromised by the withdrawal of their notified body from the medical device sector at short notice. In the absence of any specific provisions under the current legislation regarding the ongoing validity of…

Brexit transition brings short-term device regulatory stability

As the long road to the UK’s formal withdrawal from the EU came to an end, this signalled a degree of regulatory certainty at least in the UK until the end of the transition period on 31st December 2020. During this period the UK will remain aligned with EU law, and the current rules on…

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