Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘Proposed MDR Amendments and Clinical Data Requirements.’ Following Dr. Donawa’s February 2025 LinkedIn article on the current MDR’s clinical data requirements, the Commission’s December 2025 proposed MDR amendments have now been reviewed with particular attention to clinical data and…
Donawa Lifescience congratulates PainChek Ltd on receiving United States (US) Food and Drug Administration (FDA) De Novo clearance for its PainChek® Adult Intelligent Pain Assessment App (DEN240073). This groundbreaking app is the world’s first smart device-based medical device for pain assessment, designed for individuals who are unable to reliably verbalize their pain….
Donawa Lifescience provided a two-hour seminar to Chinese delegates on 28 October 2025 in conjunction with Leadvisor Global, a leading professional services platform. Donawa Lifescience had the privilege of delivering the first educational course under the Leadvisor banner: Course One – From China to the EU: Medical Device Regulations and Compliance Strategy, as part of…
This well-attended on-line Masterclass was a practical deep dive into how to successfully plan and launch pre-market clinical investigations in the EU under the MDR. Attendees discovered how to navigate country differences, identify the right investigators and sites, and streamline approvals for faster study starts. The speakers shared proven strategies to avoid costly delays and…
The 9th EAAR Annual Conference on New Medical Device Regulations (RMD 2025) took place in Brussels, Belgium, on 24-25 February 2025, 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…
On 25 September 2024, Donawa Lifescience President Dr. Maria E. Donawa spoke at the webinar titled ‘Clinical Data Requirements: EU vs. US – Critical Differences and Strategies’. Dr. Donawa was joined as a speaker by Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, Trinity College, Dublin. The webinar was hosted by MedTech Leading Voice…
Donawa Lifescience President, Maria E. Donawa, M.D., has authored a second ‘Regulatory Recap’ article on LinkedIn covering interpretational difficulties with requirements for Clinical Evaluation Plans (CEPs) under the EU Medical Device Regulation (MDR, 2017/745) titled: ‘CEPs: What Does “State of the Art” Modify?’ The topic arises because of confusion among manufacturers, notified bodies, and competent…
Donawa Lifescience President, Maria E. Donawa, M.D., has been interviewed by Amanda Maxwell of MEDTECH INSIGHT on the subject of European medical device guidance document MDCG 2024-3 concerning clinical investigation plans in the journal dated 8 April 2024. The guidance, full title ‘Guidance on the content of the clinical investigation plan for clinical investigations of…
Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘CEPs: Parameters vs outcome parameters, what’s the difference?’ The topic arises because of confusion among manufacturers, notified bodies, and competent authorities regarding the interpretation of certain requirements of the EU Medical Device Regulation (MDR, 2017/745) for clinical evaluation plans…
The 8th EAAR Annual Conference on New Medical Device Regulations (RMD2024) took 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 served as an inclusive platform for all stakeholders across the both medical…
