Donawa Lifescience | 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

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….

Donawa Lifescience delivers first on-line EU Regulatory Seminar in China

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…

UK MHRA publishes consultation on indefinite recognition of CE marked medical devices

The UK MHRA has today published its promised public consultation on indefinite recognition of CE marked medical devices for the Great Britain (GB) (England, Scotland, and Wales) market (Northern Ireland already accepts CE marked devices). The consultation invites views on the following proposals: Extending the current transitional arrangements for devices that comply with the Medical…

FDA reissues cybersecurity guidance to align with QMSR

The US Food and Drug Administration (FDA) has reissued a final guidance on quality system management considerations for medical device cybersecurity following the agency’s transition from the Quality System Regulation (QSR) to the Quality System Management Regulation (QMSR, 21 CFR 820). The new guidance replaces references to the QSR with references to the QMSR and,…

FDA updates guidelines on Clinical Decision Support Software and Wellness Devices

For the second time in a month, the US Food and Drug Administration (FDA) has updated its guidance on Clinical Decsion Support (CDS) Software. The Agency published its first final guidance on the subject in 2022, but then issued an updated version on 6 January 2026, which was superseded by a further version on 29…

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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