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 regulatory consulting company with over 24 years of practical experience, advising and supporting global healthcare product manufacturers. They specialize in regulatory documentation and cGMP advisory solutions.
**Expertise & scope**
* EU MDR/IVDR compliance
* EUDAMED registration and support
* CE marking for medical devices and IVDs
* Technical file and documentation preparation
* Clinical evaluation and PMS reporting
* Risk management
* Support for non-European manufacturers
* FDA registration services (Food, Drugs, Medical Devices)
* Cosmetic product and facility registration
**Reputation / proof points**
* Certified with ISO 27001 for data security
* Operates with a 24/7 uptime guarantee for secure cloud document delivery
* Commitment to fair pricing and on-time delivery
i3CGlobal is a regulatory consulting company with over 24 years of practical experience, advising and supporting global healthcare product manufacturers. They specialize in regulatory documentation and cGMP advisory solutions.
**Expertise & scope**
* EU MDR/IVDR compliance
* EUDAMED registration and support
* CE marking for medical devices and IVDs
* Technical file and documentation preparation
* Clinical evaluation and PMS reporting
* Risk management
* Support for non-European manufacturers
* FDA registration services (Food, Drugs, Medical Devices)
* Cosmetic product and facility registration
**Reputation / proof points**
* Certified with ISO 27001 for data security
* Operates with a 24/7 uptime guarantee for secure cloud document delivery
* Commitment to fair pricing and on-time delivery
Additional information
i3CGlobal emphasizes a commitment to data security, holding ISO 27001 certification. They ensure confidentiality and integrity of client information through secure cloud-based document management, operating 24/7. Their approach focuses on understanding regulatory requirements and developing strategies to address potential questions from authorities. They highlight their ability to initiate projects swiftly due to readily available consulting team manpower, ensuring prompt and efficient commencement and prioritizing on-time delivery for all client projects.
Key Highlights
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Over 24 years of practical experience in regulatory consulting.
Source
“We have more than 24+ years practical experience!”
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ISO 27001 certified for data security.
Source
“Certified with ISO 27001 for data security”
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Offers 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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Provides EUDAMED registration services for medical devices and IVDs.
Source
“EUDAMED Registration For Medical Device and IVDs”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Non-European medical device manufacturers seeking EU market access
- Companies requiring EUDAMED registration support
- Manufacturers needing assistance with EU MDR/IVDR compliance
How engagement typically works
- Project-based support for regulatory documentation
- Consulting services for complex regulatory tasks
- On-demand team manpower for swift project initiation
Typical deliverables
- EUDAMED registration completion
- EU MDR/IVDR technical files
- CE marking documentation
- Regulatory strategy development
Good to know
- Best when requiring expert guidance on complex EU medical device regulations
- Best when prioritizing data security and timely project completion
HQ:
Pune, India
Languages:
English
Timezones:
Asia/Kolkata
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 tasks best entrusted to experts. i3CGlobal emphasizes their readiness to initiate projects swiftly with their dedicated team, ensuring prompt commencement and prioritizing on-time delivery. They also highlight clear and consistent pricing, fair and reliable service, and secure cloud-based document 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, Vigilance, Clinical Investigations, Certificates & Notifications
Supports Actor Registration
Yes
Supports UDI
Yes
Supports Vigilance
Yes
Supports Clinical Investigations
Yes
