i3CGlobal
i3CGlobal offers expert regulatory consulting for medical devices and IVDs, specializing in EU MDR/IVDR compliance, EUDAMED registration, and CE marking. They provide comprehensive support for non-European manufacturers.
i3CGlobal is a trusted regulatory consulting company dedicated to assisting medical device and IVD manufacturers with complex compliance requirements. They specialize in navigating the intricacies of EU MDR 2017/745 and EU IVDR 2017/746, offering services such as EUDAMED registration, technical file preparation, and CE marking. With a focus on providing world-class regulatory consulting, i3CGlobal supports non-European manufacturers by acting as their European Authorized Representative and facilitating market access within the EU. Their expertise covers a wide range of services including clinical evaluation reports, risk management, and post-market surveillance. Certified with ISO 27001 for data security, i3CGlobal ensures the confidentiality and integrity of client information through secure cloud-based documentation and 24/7 availability. They are committed to fair pricing, on-time delivery, and providing reliable, efficient solutions for all regulatory needs.
About
**Who they are**
i3CGlobal is a customer-centric company specializing in regulatory consulting services for healthcare product manufacturers worldwide. They focus on ensuring compliance with EU, USA, and UK regulations.
**Expertise & scope**
* Expertise in EU MDR/IVDR compliance, EUDAMED registration, and CE marking.
* Support for non-European manufacturers seeking to enter the EU market.
* Services include regulatory documentation, registration with authorities, and cGMP advisory solutions.
* Consulting covers Food, Cosmetic, Drugs, and Medical Device sectors.
**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates with a 24/7 uptime guarantee for secure document delivery via the cloud.
* Emphasizes honesty, integrity, and fairness in its dealings.
i3CGlobal is a customer-centric company specializing in regulatory consulting services for healthcare product manufacturers worldwide. They focus on ensuring compliance with EU, USA, and UK regulations.
**Expertise & scope**
* Expertise in EU MDR/IVDR compliance, EUDAMED registration, and CE marking.
* Support for non-European manufacturers seeking to enter the EU market.
* Services include regulatory documentation, registration with authorities, and cGMP advisory solutions.
* Consulting covers Food, Cosmetic, Drugs, and Medical Device sectors.
**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates with a 24/7 uptime guarantee for secure document delivery via the cloud.
* Emphasizes honesty, integrity, and fairness in its dealings.
Additional information
i3CGlobal highlights its commitment to data security, being certified with ISO 27001. They offer round-the-clock operations with a 24/7 uptime guarantee, ensuring secure and reliable document delivery through cloud-based systems. This approach aims to provide clients with confidence in the confidentiality and integrity of their sensitive regulatory information. Their pricing is described as clear and consistent, attracting international clients who value transparency and quality assurance.
Key Highlights
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Specializes in EU MDR/IVDR compliance and EUDAMED registration.
Source
“EUDAMED Registration is a European Database an IT system proposed by the European Commission for medical devices and in-vitro diagnostic devices to meet certain requirements mentioned in regulations EU MDR 2017/745 and EU IVDR 2017/746, respectively.”
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Provides comprehensive support for non-European manufacturers.
Source
“Leading EU Representative for Medical Device providing EU Registration Service for Non European Medical Device Manufactures”
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Certified with ISO 27001 for data security.
Source
“Certified with ISO 27001 for data security, we go the extra mile to ensure the confidentiality and integrity of your information.”
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Offers 24/7 uptime guarantee for secure cloud-based document delivery.
Source
“Operating around the clock with a 24/7 uptime guarantee, we diligently work, maintain, and securely deliver documents via the cloud”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Non-European manufacturers needing EU market access
- Companies seeking EUDAMED registration support
- Medical device and IVD manufacturers
How engagement typically works
- Project-based consulting
- On-demand expert support
- Focus on timely delivery
Typical deliverables
- EUDAMED registration filings
- EU MDR/IVDR compliance documentation
- CE marking support
- Regulatory strategy development
Good to know
- Services are currently available in English only.
HQ:
Pune, India
Languages:
English
Timezones:
Asia/Kolkata
Claim status:
Listed
Services & Capabilities
Best EUDAMED Registration| Compare & Get Quotes
Jurisdictions:
EU
Countries:
NL, PL, BE, ES, DE, AT, FR
Industries:
Medical devices, IVD, SaMD, Manufacturing
Portfolio:
26-100
Onboarding time:
3–21 days
Pricing model:
Onboarding + annual retainer
Starting from:
EUR 2,500
Included services:
Actor/SRN registration support, UDI/Device module readiness, Data preparation & validation, Training enablement
Supports Actor Registration:
Yes
Supports UDI:
No
Supports Data Load:
No
Modules Supported:
Actor/SRN, Vigilance, Certificates, Clinical investigations
Supports Training Enablement:
No
Data Load Support Level:
Training only
Turnaround SLA:
Custom
Additional eudamed_reg_support Details
Included Services Detailed
Actor/SRN registration readiness review and submission support (seed scope), UDI/Device data preparation, validation, and upload workflow support (seed scope), Internal data governance mapping (roles, owners, approvals) (seed scope), Training enablement for EUDAMED operational tasks (seed scope)
Excluded Services
Notified Body services or conformity assessment decision-making, Legal representation with Competent Authorities, Clinical evaluation or performance evaluation writing (unless separately scoped)
Onboarding Steps
The website mentions that regulatory documentation and registrations are complex and resource-intensive, advising clients to entrust these to experts. It also states that their team is prepared to initiate projects swiftly, ensuring prompt and efficient commencement.
Data Load Notes
Data load support level indicates whether uploads are done-for-you, guided, or training-only (seed summary).
Modules Supported
Actor, UDI/Devices (implied by MDR/IVDR focus)
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Yes
Supports Clinical Investigations
Yes
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