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, ensuring compliance with EU, USA, and UK regulations.
**Expertise & scope**
* Expert regulatory consulting for medical devices and IVDs.
* Specialization in EU MDR/IVDR compliance, EUDAMED registration, and CE marking.
* Comprehensive support for non-European manufacturers.
* Services include EUDAMED registration, UDI registration, and Actor registration.
* Consulting for Food, Cosmetic, and Drugs regulatory requirements.
**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates around the clock with a 24/7 uptime guarantee.
* Offers transparent pricing and a guarantee of quality.
i3CGlobal is a customer-centric company specializing in regulatory consulting services for healthcare product manufacturers worldwide, ensuring compliance with EU, USA, and UK regulations.
**Expertise & scope**
* Expert regulatory consulting for medical devices and IVDs.
* Specialization in EU MDR/IVDR compliance, EUDAMED registration, and CE marking.
* Comprehensive support for non-European manufacturers.
* Services include EUDAMED registration, UDI registration, and Actor registration.
* Consulting for Food, Cosmetic, and Drugs regulatory requirements.
**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Operates around the clock with a 24/7 uptime guarantee.
* Offers transparent pricing and a guarantee of quality.
Additional information
i3CGlobal emphasizes a commitment to honesty, integrity, and fairness in all its dealings, aiming to build trust with clients. They highlight their ability to initiate projects swiftly due to readily available regulatory consulting team manpower, ensuring prompt and efficient commencement. The company also stresses its dedication to data security, being ISO 27001 certified and operating 24/7 to maintain and securely deliver documents via the cloud, providing a reliable and secure consulting service.
Key Highlights
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Specializes in EU MDR/IVDR compliance, EUDAMED registration, and CE marking.
Source
“i3CGlobal offers expert regulatory consulting for medical devices and IVDs, specializing in EU MDR/IVDR compliance, EUDAMED registration, and CE marking.”
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Provides comprehensive support for non-European manufacturers seeking EU market access.
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 regulatory consulting services for Food, Cosmetic, and Drugs, in addition to Medical Devices.
Source
“I3CGlobal is a dynamic and customer centric company specializing in delivering Food, Cosmetic, Drugs, and Medical Device Regulatory Consulting Services for healthcare product manufacturers worldwide.”
Certifications & Trust Signals
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ISO 27001 certified 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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Operates 24/7 with a guaranteed uptime for reliable service delivery.
Source
“Operating around the clock with a 24/7 uptime guarantee, we diligently work, maintain, and securely deliver documents via the cloud...”
Buyer Snapshot
Best for
- Non-European medical device and IVD manufacturers seeking EU market access.
- Companies requiring assistance with EUDAMED registration and compliance.
How engagement typically works
- Customer-centric approach.
- Focus on transparency and fairness in pricing.
- Commitment to on-time delivery.
Typical deliverables
- EUDAMED registration support.
- EU MDR/IVDR compliance consulting.
- CE marking guidance.
- UDI registration support.
- Actor registration support.
Good to know
- Best when requiring specialized regulatory expertise for complex documentation and registrations.
HQ:
Pune, India
Languages:
English
Timezones:
Asia/Kolkata
Claim status:
Listed
Services & Capabilities
Find 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 time-consuming, and it is best to entrust these to experts. It also highlights swift project initiation and prompt, efficient commencement of projects with a focus on on-time delivery.
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
Supports Actor Registration
true
Supports UDI
true
Supports Vigilance
Implied through MDR/IVDR compliance support
Supports Clinical Investigations
Implied through MDR/IVDR compliance support
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