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COMPANY NEWS

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),…

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…

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…

Global News

MDR update

Progress has been made on several fronts in relation to the roll-out of regulations and guidance for the Medical Device Regulation (MDR, 2017/745) in recent weeks. Firstly, the 16th and 17th MDR Notified Bodies have been named on the NANDO database, these being DQS Medizinprodukte GmbH, Germany, making it the sixth Notified Body to be…

MHRA publishes information on UK post-Brexit device regs

The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has published in its website an overview of the post-Brexit regulations that will apply to medical devices in the event of a ‘no deal’ or ‘hard’ Brexit. It confirms that the UK will leave the European Union (EU) on 31 December 2020, and so the new…

Brexit and MDR present double whammy for UK MedTech

Two reports do not provide easy reading for UK MedTech, as the government warns about post-Brexit device shortages and a survey finds UK SMEs still unprepared for the MDR, despite having an extra year to prepare, thanks to the coronavirus. In a letter to suppliers, Steve Oldfield, Chief Commercial Officer at the Department of Health…

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