Donawa Lifescience | European Device CRO - Contract Research Organization

A Leading CRO and Regulatory Consultancy for US and EU Medical Devices and IVDs
Clinical and regulatory services aligned with client objectives and regulatory expectations

CRO
SERVICES

Full-service clinical study management, aligned with EU and US regulatory expectations, from study planning through conduct, avoiding delays, redesigns, and repeat studies.

REGULATORY AND ETHICS SUBMISSIONS

CRO-led regulatory and ethics committee submissions that minimize authority questions, streamline approvals, and keep clinical programs moving forward.

Regulatory
And Quality

Regulatory and quality support for medical devices and IVDs, providing early clarity on requirements and preventing late-stage compliance gaps and rework.

clinical
evaluation

Development of MDR- and Notified Body-aligned clinical evaluation plans and reports, to support regulatory review and provide a robust template for future updates.

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

Donawa Lifescience helps Tournicare achieve US marketing clearance for ARMA OTC BPM

The Australian start-up company Tournicare Pty Ltd has achieved US marketing clearance from the Food and Drug Administration (FDA) for its ARMA over-the-counter Blood Pressure Monitor (BPM) via the 510(k) pre-market notification process with regulatory assistance from Donawa Lifescience. Tournicare announced its success in a LinkedIn post in mid-June. Tournicare CEO Niels van Sparrentak explains:…

Maria Donawa publishes LinkedIn article on Proposed MDR Amendments and Clinical Data Requirements

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…

PainChek® secures FDA De Novo Clearance with clinical management from Donawa Lifescience

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….

MDCG Position Paper published on Management of SSCP/SSP in EUDAMED

The EU Medical Device Coordination Group (MDCG) has published a new guidance document, MDCG 2026-4, titled ‘MDCG Position Paper: Management of SS(C)P in EUDAMED after mandatory use’. The document explains that “The summary of safety and clinical performance and the summary of safety and performance (SSCP and SSP respectively), are to be uploaded by the…

FDA drafts new rule on use of electronic instructions for use

The US Food and Drug Administration (FDA) has released draft wording for a new rule that would allow gretaer use of electronic instructions for use for many types of medical device. The proposed rule, if finalized, would clarify that the “adequate directions for use” requirement under section 502(f) of the Federal Food, Drug, and Cosmetic…

FDA publishes guidance Q&A on Clinical Support Software

The US Food and Drug Administration has recently published a Q&A document on the subject of Clinical Support Software, following release of full guidance on the topic in January 2026. The Q&A explains that “Clinical Decision Support (CDS) software are important tools in modern health care. While some CDS software has been excluded from the…

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A Leading CRO and Regulatory Consultancy for US and EU Medical Devices and IVDs Clinical and regulatory services aligned with client objectives and regulatory expectations

CRO SERVICES

REGULATORY AND ETHICS SUBMISSIONS

Regulatory And Quality

clinical evaluation

CRO SERVICES

clinical study submissions

Regulatory And Quality

clinical evaluation

A Leading CRO and Regulatory Consultancy for US and EU Medical Devices and IVDs
Clinical and regulatory services aligned with client objectives and regulatory expectations

CRO
SERVICES

Regulatory
And Quality

clinical
evaluation

clinical study
submissions

Regulatory
And Quality

clinical
evaluation