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…

FDA replaces QSIT with new Compliance Program Manual

To coincide with mandatory use of the Agency’s Quality Management System Regulation (QMSR, 21 CFR 820) requirements, FDA has also replaced its ‘Quality System Inspection Technique’ (QSIT) guidance for Inspectors with a ‘Compliance Program Manual: Inspection of Medical Device Manufacturers’, with effect from 2 February 2026, explaining that the program has been updated to align…

ECRI publishes its Top Ten List for 2026

The US Food and Drug Administration (FDA) has published the final version of its guidance document titled ‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’, superseding the draft published in June 2018.
As in the draft, the guidance provides advice to medical device manufacturers on the following types of …

EU Commission publishes promised proposed updates to MDR and IVDR

On 16 December 2025, the EU Commission published its ‘Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards 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