Donawa (EU Authorized Representative)
Donawa Lifescience Consulting Srl
Donawa Lifescience Consulting is an EU Authorized Representative offering comprehensive CRO services for medical devices and IVDs. They specialize in regulatory submissions, clinical evaluations, and quality support to ensure compliance with EU and US regulations.
Donawa Lifescience Consulting (DLC) is a full-service Contract Research Organization (CRO) and EU Authorized Representative specializing in the medical device and IVD sectors. They provide end-to-end support for clinical study management, from planning through conduct, ensuring alignment with EU and US regulatory expectations to avoid delays and rework. DLC excels in managing regulatory and ethics committee submissions, aiming to minimize authority questions and streamline approvals. They offer expert regulatory and quality support, providing early clarity on requirements for medical devices and IVDs to prevent late-stage compliance gaps. Their services include the development of MDR- and Notified Body-aligned clinical evaluation plans and reports, crucial for regulatory review and future updates. With extensive experience in developing clinical evaluation reports (CERs), clinical data strategies, and determining device equivalence, Donawa is a trusted partner for navigating complex regulatory landscapes. They assist with high-quality submissions to US and EU regulatory authorities, Ethics Committees, and site agreement negotiations, offering expert guidance on any EU or US related regulatory or quality system issue for all types of medical devices, including IVDs and combination products.
About
**Who they are**
Donawa Lifescience Consulting (DLC) is a specialized consultancy with over 25 years of experience in navigating complex regulatory landscapes for medical devices and in vitro diagnostic devices (IVDs) in Europe and the United States.
**Expertise & scope**
* EU Authorized Representative (AR) services, including compliance with MDR/IVDR and adherence to guidance documents like MDCG 2022-16.
* US regulatory services, encompassing FDA facility registration, product listing, pre-market submissions (510(k), PMA, de novo), Medical Device Reporting (MDR), and Corrections and Removals.
* Support for In Vitro Diagnostic Devices (IVDs) under both the IVDD and the upcoming IVDR, including CE marking and performance evaluations.
* Quality system development and compliance, aligning with EN ISO 13485 for Europe and 21 CFR 820 (QSR) for the US, including SOP revision and internal training.
* Software compliance services for medical devices, including computer system validation and adherence to IEC 62304.
* Training on US and European regulatory and quality system requirements.
**Reputation / proof points**
* Founding member of the European Association of Authorised Representatives (EAAR), promoting professional conduct and competence.
* Possesses a 'person responsible for regulatory compliance' (PRRC) meeting new MDR/IVDR requirements.
* Offers US Agent services through its US-based entity, Donawa Lifescience, Inc.
* Extensive experience in assisting clients with FDA inspections, including responding to Form 483s and managing Warning Letters.
Donawa Lifescience Consulting (DLC) is a specialized consultancy with over 25 years of experience in navigating complex regulatory landscapes for medical devices and in vitro diagnostic devices (IVDs) in Europe and the United States.
**Expertise & scope**
* EU Authorized Representative (AR) services, including compliance with MDR/IVDR and adherence to guidance documents like MDCG 2022-16.
* US regulatory services, encompassing FDA facility registration, product listing, pre-market submissions (510(k), PMA, de novo), Medical Device Reporting (MDR), and Corrections and Removals.
* Support for In Vitro Diagnostic Devices (IVDs) under both the IVDD and the upcoming IVDR, including CE marking and performance evaluations.
* Quality system development and compliance, aligning with EN ISO 13485 for Europe and 21 CFR 820 (QSR) for the US, including SOP revision and internal training.
* Software compliance services for medical devices, including computer system validation and adherence to IEC 62304.
* Training on US and European regulatory and quality system requirements.
**Reputation / proof points**
* Founding member of the European Association of Authorised Representatives (EAAR), promoting professional conduct and competence.
* Possesses a 'person responsible for regulatory compliance' (PRRC) meeting new MDR/IVDR requirements.
* Offers US Agent services through its US-based entity, Donawa Lifescience, Inc.
* Extensive experience in assisting clients with FDA inspections, including responding to Form 483s and managing Warning Letters.
Additional information
Donawa Lifescience Consulting provides tailored training sessions on US and European regulatory and quality system requirements for medical devices. These interactive sessions can be conducted at client facilities or at their office in Rome. They also offer specialized computer system validation and compliance services for medical devices containing software components, ensuring adherence to both European and US standards like IEC 62304 and ISO 14971.
Key Highlights
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Donawa Lifescience has over 25 years of experience with the US FDA regulatory system.
Source
“Donawa Lifescience has more than 25 years’ experience in dealing with various aspects of the US Food and Drug Administration (FDA) regulatory system.”
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Offers EU Authorized Representative services that meet the requirements of the MDR/IVDR, including having a designated PRRC.
Source
“The new Regulations also stipulate that ARs must have a ‘person responsible for regulatory compliance’ (PRRC), with specific educational and work experience requirements. Donawa Lifescience meets these new requirements...”
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Is a founding member of the European Association of Authorised Representatives (EAAR).
Source
“Donawa Lifescience is also a founding member of the European Association of Authorised Representatives, an alliance of European Authorised Representatives who have joined forces to promote professional conduct and competence.”
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Provides comprehensive support for In Vitro Diagnostic Devices (IVDs) under the upcoming IVDR.
Source
“Donawa provides a fully comprehensive service to help with IVD compliance in Europe and the US, from simply answering questions on the regulations to a significant involvement in quality system updates, technical documentation preparation...”
Certifications & Trust Signals
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Offers US Agent services through its US-based entity, Donawa Lifescience, Inc.
Source
“Donawa can provide US Agent services via its company based in the US: Donawa Lifescience, Inc.”
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Has extensive experience assisting clients with FDA inspections and responding to regulatory observations.
Source
“Donawa has helped many clients respond correctly to Form 483s, by putting in place realistic and comprehensive corrective action plans...”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking EU Authorized Representative services.
- Companies requiring US FDA regulatory support, including submissions and compliance.
- Manufacturers needing to establish or update quality management systems for EU and US markets.
How engagement typically works
- Direct consultancy and advisory services.
- Development and implementation of regulatory strategies.
- Training and capacity building for internal teams.
Typical deliverables
- EU Authorized Representative agreements and support.
- FDA registration and submission packages.
- Quality system documentation (SOPs, technical files).
- Software compliance documentation.
- Post-market surveillance and vigilance reporting support.
Good to know
- Best when engaging for complex regulatory challenges in the EU and US markets.
- Ideal for companies needing to ensure compliance with MDR and IVDR.
HQ:
Rome, IT
Languages:
English, Italian
Timezones:
Europe/Rome
Claim status:
Listed
Services & Capabilities
Best EU Authorized Rep (EC REP) | Compare & Get Quotes
Jurisdictions:
EU
Countries:
IT, FR, DE, ES
Industries:
Medical devices, IVD, Healthcare
Portfolio:
6-25, 26-100
Onboarding time:
3–21 days
Pricing model:
Per project
Starting from:
EUR 2,500
Included services:
EU Authorized Representative (EC REP) designation, Authority liaison and document availability support, Vigilance escalation and FSCA coordination, Labeling/EC REP identification review, Post-market support workflows (complaints, vigilance escalation)
Supports MDR:
Yes
Supports IVDR:
Yes
Device Classes Supported:
IVD
EU Entity Country:
Italy
Can Be Named On Label:
Yes
Post Market Support:
Yes
Labeling Review:
Yes
Vigilance Contact Support:
Yes
Fsca Recall Support:
Yes
Additional eu_ar Details
Device Classes Supported
All
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
EU
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Onboarding involves understanding client needs, designating an AR (if applicable), and providing expert regulatory advice. For US Agent services, Donawa Lifescience, Inc. acts on behalf of the client. For quality systems, they offer gap analysis and mock FDA inspections.
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