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…
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…
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),…
The US Food and Drug Administration (FDA) has announced the finalization of guidance to help institutional review boards (IRBs), clinical investigators, and sponsors comply with informed consent regulations for clinical investigations. The 61-page guidance revises a draft guidance issued in July 2014 and supersedes a guidance issued in September 1998. The document provides general guidance…
The industrry association for medical device notified bodies, TEAM-NB, explains that while extending the deadline for transition to EU Medical Device Regulation (MDR) compliance has been a positive move, there is more regulators and industry can do to ensure manufacturers can recertify their products on time to meet the new deadlines. In its recently issude…
The US Food and Drug Administration (FDA) has announced the user fees that will be payable by medical device manufacturers for interactions with the Agency’s Center for Devices and Radiological Health (CDRH) during Fiscal Year 2024, starting on 1 October 2023. The new fees, which include an increase of around 7.6% over the previous year,…
