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),…
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…
The European Medicines Agency has updated its 2015 Question and Answer guidance document on the combination product consultation procedure to align its content with the requirements of the Medical Device Regulation (MDR, 2017/745). The document has the catchy title of ‘Questions & Answers on the consultation procedure to the European Medicines Agency by notified bodies…
Eurofins Expert Services Oy, located in Finland, has become the twentieth Notified Body (NB) to be designated under the EU Medical Device Regulation (MDR, 2017/745) according to the NANDO database. Eurofins is Notified Body number 0537 and remains designated under the Medical Device Directive (MDD, 93/42/EEC) and In Vitro Diagnostics Directive (IVDD, 98/79/EC). The European…
The US Food and Drug Administration (FDA) has launched a new webpage aimed at providing support and advice to medical device manufacturers on the steps needed to demonstrate device biocompatibility in submissions to the Agency. The website introduces the subject by stating: “These resource pages are intended to explain terms and concepts important for the…
