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.
* 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.
* Extensive experience in assisting clients with FDA inspections, including responding to Form 483s and managing Warning Letters.
Additional information
Donawa Lifescience offers tailored training sessions on US and European regulatory and quality system requirements for medical devices. These sessions can be conducted at client facilities or at their office in Rome. They also provide 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. For US market entry, they offer gap analysis and mock FDA inspections to identify and resolve discrepancies with QSR requirements, and can assist with pre-audit and post-inspection corrective actions.
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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Specializes in In Vitro Diagnostic Devices (IVDs) and general medical devices for Europe and the US.
Source
“Donawa Lifescience is specialised in in vitro diagnostic devices (IVDs) as well as ‘general’ medical devices, being able to offer regulatory and quality system support for both Europe and the US”
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Offers US Agent services through its US-based company, Donawa Lifescience, Inc.
Source
“Donawa can provide US Agent services via its company based in the US: Donawa Lifescience, Inc.”
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Provides comprehensive support for quality systems, including EN ISO 13485 and US 21 CFR 820 (QSR).
Source
“In Europe, what is known as the ‘Full Quality Assurance System’ in the prior Directives and new Regulations is broadly equivalent to EN ISO 13485, ‘Medical devices, Quality management systems, Requirements for regulatory purposes’”
Certifications & Trust Signals
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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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Meets new MDR/IVDR requirements for a 'person responsible for regulatory compliance' (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”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking EU Authorized Representative services.
- Companies needing to navigate US FDA regulations, including submissions and reporting.
- Manufacturers requiring quality system compliance for European and US markets.
How engagement typically works
- Direct consultancy and advisory services.
- Development and implementation of regulatory and quality documentation.
- On-site and remote training sessions.
Typical deliverables
- EU Authorized Representative services.
- FDA registration and submission support.
- Quality Management System documentation (ISO 13485, QSR).
- Software compliance documentation.
- Training materials and sessions.
Good to know
- Best when engaging for complex regulatory challenges in the EU and US.
- Requires clear definition of scope for specific service needs.
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
Class I, IIa, IIb, III (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
EU Entity Country
EU (specific country not stated, but services cover EEA)
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Contact for information on services and assistance. Standard AR agreements are available.
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