i3CGlobal

i3CGlobal offers expert regulatory consulting for medical device manufacturers, specializing in FDA QSR, MDR, and IVDR compliance. They provide comprehensive support for CE marking, ISO 13485 certification, and quality system implementation.

i3CGlobal is a trusted regulatory consulting company dedicated to assisting medical device manufacturers navigate complex global regulations. They specialize in ensuring compliance with FDA QSR, MDR, and IVDR, offering services such as CE marking, ISO 13485 certification, and the development of robust quality management systems (QMS). With a focus on timely delivery and transparent pricing, i3CGlobal provides expert guidance on regulatory documentation, registrations, and technical file preparation. Their team of experienced consultants is equipped to handle projects of all sizes, from startups to established companies, ensuring adherence to international standards and requirements. Leveraging their expertise, i3CGlobal helps clients achieve critical certifications and market access. They offer tailored solutions for medical device quality management systems (MD-QMS), including implementation of ISO 13485, IEC 62304, and compliance with 21 CFR 820 (QMSR). Their services are designed to enhance business opportunities by boosting buyer and investor confidence through demonstrated quality and regulatory adherence.

About

**Who they are**
i3CGlobal is a regulatory consulting company that provides expert support for medical device manufacturers. They specialize in navigating complex regulatory landscapes to ensure compliance and facilitate market access.

**Expertise & scope**
* FDA QSR, MDR, and IVDR compliance
* CE marking assistance
* ISO 13485 certification and implementation
* Quality system development and implementation
* Technical file and documentation preparation
* Risk management
* Clinical evaluation support
* Post-market surveillance (PMS) reporting
* Software CE marking
* Support for drugs, food/food supplements, and cosmetics regulatory requirements

**Reputation / proof points**
* Certified with ISO 27001 for data security
* Operates with a 24/7 uptime guarantee for secure cloud documentation delivery

Additional information

i3CGlobal emphasizes a client-centric approach, offering clear and consistent pricing with a guarantee of quality. They are committed to data security, holding ISO 27001 certification, and ensure confidentiality and integrity of client information through secure cloud-based document management. Their team of dedicated, full-time regulatory experts is prepared to initiate projects swiftly, prioritizing on-time delivery. They address challenges related to regulatory documentation and registrations, which are noted as complex, resource-intensive, and time-consuming tasks best entrusted to experts.

Key Highlights

  • Specializes in FDA QSR, MDR, and IVDR compliance for medical devices. Source
    “i3CGlobal offers expert regulatory consulting for medical device manufacturers, specializing in FDA QSR, MDR, and IVDR compliance.”
  • Provides comprehensive support for ISO 13485 certification and CE marking. Source
    “ISO 13485 certification is essential for medical device companies that want to demonstrate compliance with regulatory standards”
  • Certified with ISO 27001 for data security, ensuring confidentiality and integrity of information. Source
    “Certified with ISO 27001 for data security, we go the extra mile to ensure the confidentiality and integrity of your information.”
  • Offers clear and consistent pricing with a guarantee of quality. Source
    “Our clear and consistent pricing on the I3CGlobal website has attracted customers from around the world.”

Certifications & Trust Signals

  • 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.”

Buyer Snapshot

Best for
  • Medical device manufacturers seeking FDA QSR, MDR, or IVDR compliance
  • Companies pursuing ISO 13485 certification
  • Businesses needing support with CE marking and technical documentation
How engagement typically works
  • Project-based consulting
  • Regulatory documentation support
  • Quality system implementation guidance
Typical deliverables
  • Regulatory strategy and submissions
  • ISO 13485 certified quality management systems
  • Technical files and documentation packages
  • Risk management files
  • SOP templates and procedures
Good to know
  • Best when requiring specialized regulatory expertise for complex compliance requirements.

Pricing

Model: Custom pricing
Public range: Publicly listed: $50.00 - $7000.00
Notes: Based on publicly listed information for SOP templates and potential project costs; final fees depend on scope.
“Pricing: cost,; $ 2000; $ 3000; $7000; $ 3000”
HQ: United States, India
Languages: English
Timezones: EST, PST
Status: listed

Services & Capabilities

FDA QMSR Transition & Inspection Readiness (ISO 13485 Alignment)

Jurisdictions: US
Countries: US
Industries: Medical Devices, IVD
Onboarding time: 7–21 days
Pricing model: Custom pricing
Service Types: QMSR/ISO 13485 Gap Assessment, Internal Audit Program Upgrade, Mock FDA Inspection
Earliest Start: flexible
Delivery Mode: Hybrid
Inspection Experience: ISO 13485 lead auditor capability

Additional fda_qmsr_transition_inspection_readiness Details

Service Types
QMSR/ISO 13485 Gap Assessment, SOP/Documentation Remediation, Design Controls/DHF Modernization, CAPA & Nonconformance Remediation, Supplier Controls/Quality Agreements, Internal Audit Program Upgrade, Mock FDA Inspection, Training & Competency Programs, 483 Response & Remediation Support
Earliest Start
flexible
Delivery Mode
Hybrid
Inspection Experience
Supports mock inspections regularly
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