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

Donawa (EU Authorized Representative) is a specialized consultancy with over 25 years of experience in navigating complex medical device and IVD regulations across Europe and the United States. They offer comprehensive services as an EU Authorized Representative, ensuring compliance with MDR and IVDR, and possess a designated Person Responsible for Regulatory Compliance (PRRC). Donawa provides end-to-end support for US market entry, including facility registration, device listing, pre-market submissions (510(k), PMA, de novo), and Medical Device Reporting (MDR). Their expertise extends to quality system development and implementation, aligning with EN ISO 13485 and US FDA's Quality System Regulation (QSR). Donawa also offers specialized software compliance services, addressing IEC 62304 and other relevant standards, and provides tailored training programs on US and EU regulatory requirements.

Additional information

Donawa Lifescience Consulting provides specialized support for manufacturers navigating complex regulatory landscapes in both Europe and the United States. Their services extend to assisting with the transition to new regulations like the EU MDR and IVDR, which require significant updates to technical documentation and quality systems. For US market entry, they offer comprehensive support including acting as the US Agent, managing FDA facility registrations, and preparing pre-market submissions. Their expertise in quality systems covers both ISO 13485 and the FDA's QSR, with practical assistance for inspections and corrective actions. They also offer tailored training programs to enhance client understanding of these requirements.

Key Highlights

  • Specializes in EU Authorized Representative services for medical devices and IVDs, ensuring compliance with MDR/IVDR. 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)”
  • Offers comprehensive US regulatory services, including FDA facility registration, product listing, and pre-market submissions. Source
    “We can work with you from the beginning with assistance for registering your facility and listing your products, through to developing pre-market submissions”
  • Provides expert support for In Vitro Diagnostic Devices (IVDs) compliance in Europe and the US, including 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”
  • Assists with quality system requirements for both EU (EN ISO 13485) and US (21 CFR 820) regulations, including FDA inspection support. 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”
  • Offers specialized software compliance services for medical devices, addressing European and US requirements. Source
    “Donawa Lifescience can provide specialized computer system validation and compliance services, including evaluation of existing documentation and advice on any actions that may be needed”

Certifications & Trust Signals

  • 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”
  • Has over 25 years of experience in dealing with the US Food and Drug Administration (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.”
  • Maintains a US-based entity, Donawa Lifescience, Inc., to provide US Agent services. Source
    “Donawa can provide US Agent services via its company based in the US: Donawa Lifescience, Inc.”

Buyer Snapshot

Best for
  • Medical device and IVD manufacturers seeking EU Authorized Representation.
  • Companies requiring US FDA regulatory support, including US Agent services.
  • Manufacturers needing assistance with quality system implementation and compliance for EU and US markets.
How engagement typically works
  • Project-based support for specific regulatory submissions.
  • Retainer-based services for ongoing compliance and representation.
  • Customized training sessions for internal teams.
Typical deliverables
  • EU Authorized Representative services.
  • FDA registration and listing support.
  • Pre-market submission dossiers (510(k), PMA, de novo).
  • Quality system documentation and gap analysis.
  • Software compliance documentation.
  • Training materials and delivery.
Good to know
  • Best when engaging for complex regulatory challenges across EU and US jurisdictions.
  • Requires clear definition of scope for project-based engagements.
HQ: Rome, IT
Languages: English, Italian
Timezones: Europe/Rome
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
Not explicitly stated, but services are for the EU market.
Fsca Recall Support
Yes
Post Market Support
Yes
Vigilance Contact Support
Yes
Onboarding Steps
Contact Donawa for information on services and assistance. For US Agent services, contact them to discuss how they can help.
Request quotes
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