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. They offer comprehensive services to ensure compliance with global regulatory requirements.
**Expertise & scope**
* EU Authorized Representative (AR) services, including adherence to MDR/IVDR guidance documents and ensuring a Person Responsible for Regulatory Compliance (PRRC).
* US regulatory support, covering FDA facility registration, product listing, pre-market submissions (including 510(k)s, de novos, PMAs), Medical Device Reporting (MDR), and Corrections and Removals.
* In Vitro Diagnostic Devices (IVD) compliance for both Europe (IVDR) and the US, including CE marking, performance evaluations, and FDA submissions.
* Quality System support, aligning with EN ISO 13485 for Europe and 21 CFR 820 (QSR) for the US, including SOP revision and 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).
* Over 25 years of experience in US FDA regulatory systems.
* Office located in the historic centre of Rome.
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. They offer comprehensive services to ensure compliance with global regulatory requirements.
**Expertise & scope**
* EU Authorized Representative (AR) services, including adherence to MDR/IVDR guidance documents and ensuring a Person Responsible for Regulatory Compliance (PRRC).
* US regulatory support, covering FDA facility registration, product listing, pre-market submissions (including 510(k)s, de novos, PMAs), Medical Device Reporting (MDR), and Corrections and Removals.
* In Vitro Diagnostic Devices (IVD) compliance for both Europe (IVDR) and the US, including CE marking, performance evaluations, and FDA submissions.
* Quality System support, aligning with EN ISO 13485 for Europe and 21 CFR 820 (QSR) for the US, including SOP revision and 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).
* Over 25 years of experience in US FDA regulatory systems.
* Office located in the historic centre of Rome.
Additional information
Donawa Lifescience 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 Rome office. 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. For companies entering the US market, Donawa offers gap analysis and mock FDA inspections to identify and resolve discrepancies with QSR requirements, and can assist with pre- and post-inspection actions, including responses to Form 483s and Warning Letters.
Key Highlights
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Offers EU Authorized Representative services, meeting requirements for MDR/IVDR and ensuring a Person Responsible for Regulatory Compliance (PRRC).
Source
“Manufacturers of medical devices regulated by the Medical Device Directives/Regulations who are located outside the European Economic Area (EEA) must designate an Authorized Representative (AR)... Donawa Lifescience meets these new requirements and is able to provide expert regulatory advice to its AR clients on an as-needed basis.”
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Provides over 25 years of experience in US FDA regulatory systems, including facility registration, product listing, and pre-market submissions.
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) compliance for both Europe (IVDR) and the US, covering CE marking and FDA submissions.
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, covering CE marking, performance evaluations, and FDA submissions...”
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Offers comprehensive quality system support, aligning with EN ISO 13485 for Europe and 21 CFR 820 (QSR) for the United States.
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... For the US, the quality system requirements are documented in 21 CFR 820, otherwise known as the Quality System Regulation (QSR).”
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Is a founding member of the European Association of Authorised Representatives (EAAR), promoting professional conduct and competence.
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.”
Certifications & Trust Signals
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Founded in 2012, with over 10 years of experience specifically in EU Authorized Representative services.
Source
“In January 2012, the European Commission published a guidance document for Authorised Representatives...”
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Offers training on US and European regulatory and quality system requirements for medical devices.
Source
“Donawa Lifescience offers training on a variety of subjects pertaining to US and European regulatory and quality system requirements for medical devices.”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking EU Authorized Representative services.
- Companies needing to navigate US FDA regulations for market entry and post-market compliance.
- Manufacturers requiring quality system development and compliance support for EU and US markets.
How engagement typically works
- Project-based regulatory support.
- Retainer-based services for ongoing compliance needs.
- Customized training programs.
Typical deliverables
- EU Authorized Representative designation and ongoing support.
- FDA submissions (510(k), PMA, de novo).
- Quality system documentation and implementation (ISO 13485, QSR).
- Software compliance documentation.
- Regulatory training materials and delivery.
Good to know
- Best when engaging for complex regulatory challenges in the medical device and IVD sectors.
- Ideal for companies requiring specialized expertise in both European and US regulatory frameworks.
HQ:
Rome, IT
Languages:
English, Italian
Timezones:
Europe/Rome
Claim status:
Listed
Services & Capabilities
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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 (general, specific country not stated)
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Onboarding involves understanding client needs, designating qualified companies as AR, and ensuring compliance with regulatory requirements including PRRC. For US Agent services, designation in the FDA's registration database is required.
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