Donawa Lifescience | Device CRO - Contract Research Organization

A Leading CRO, Regulatory and Quality Systems Consultancy for Medical Devices and In Vitro Diagnostics

CRO
SERVICES

Your CRO partner for successful management of clinical studies in the EU, US and Canada for medical devices, IVDs and combination products.

clinical study
submissions

High quality submissions to US and EU regulatory authorities, assistance with Ethics Committees, and negotiation of site agreements.

Regulatory
And Quality

Expert assistance with any EU or US related regulatory or quality system issue for all types of medical devices, including IVDs and combination products.

clinical
evaluation

Extensive experience in developing clinical evaluation reports (CERs), clinical data strategies, and determination of device equivalence.

CRO SERVICES

Your CRO partner for successful management of clinical studies in the EU, US and Canada for medical devices, IVDs and combination products.

clinical study
submissions

High quality submissions to US and EU regulatory authorities, assistance with Ethics Committees, and negotiation of site agreements.

Regulatory
And Quality

Expert assistance with any EU or US related regulatory or quality system issue for all types of medical device, including IVDs and combination products.

clinical
evaluation

Extensive experience in developing clinical evaluation reports (CERs), clinical data strategies, and determination of device equivalence.

COMPANY NEWS

Maria Donawa posts a second article on device clinical evaluation plans on LinkedIn

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…

Clinical Data Requirements: EU vs. US – Critical Differences and Strategies

On 25 September 2024, Donawa Lifescience President Dr. Maria E. Donawa will speak at the webinar titled ‘Clinical Data Requirements: EU vs. US – Critical Differences and Strategies’, starting at 10:00 EST. Dr. Donawa will be joined as a speaker by Tom Melvin, Associate Professor of Medical Device Regulatory Affairs, Trinity College, Dublin. The webinar…

Maria Donawa interviewed by MEDTECH INSIGHT

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…

FDA announces user fees for fiscal 2025

The US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) has published the user fees applicable to submissions, etc for fiscal year 2025, running from 1 October 2024 to 30 September 2025. The new fees represent a 12% increase over the 2024 fees. Further details are available from the FDA website….

EU publishes final text of Artificial Intelligence Act

The European Commission has published the final text of the Artificial Intelligence Act (AIA) which establishes a legal framework for “human centric and trustworthy” AI for medical devices, in vitro diagnostic devices (IVDs) and other products. The Act also sets harmonized rules for placing such products on the Community market. The AIA was published in…

Joint CAMD/HMA statement published on status of EU Regulatory System

The Competent Authorities for Medical Devices (CAMD) and the Heads of Medicines Agencies (HMA) have published a joint statement on the current status of the EU regulatory system for medical devices and in vitro medical devices. The statement, copy available from here, makes it clear that “there are challenges in applying the Regulations for all…

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A Leading CRO, Regulatory and Quality Systems Consultancy for Medical Devices and In Vitro Diagnostics

CRO SERVICES

clinical study submissions

Regulatory And Quality

clinical evaluation

CRO SERVICES

clinical study submissions

Regulatory And Quality

clinical evaluation

CRO
SERVICES

clinical study
submissions

Regulatory
And Quality

clinical
evaluation

clinical study
submissions

Regulatory
And Quality

clinical
evaluation