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 firm specializing in medical device compliance. They offer expert guidance for manufacturers navigating complex regulatory landscapes.
**Expertise & scope**
* FDA QSR, QMSR, and MDR compliance
* ISO 13485 certification and implementation
* CE marking for medical devices and IVDs
* Technical file and documentation preparation for MDR and IVDR
* Software CE marking and IEC 62304 compliance
* Gap assessments and internal audit programs
* CAPA (Corrective and Preventive Actions) support
* Consulting for drugs, food/food supplements, and cosmetics
**Reputation / proof points**
* Certified with ISO 27001 for data security
* Offers 24/7 uptime guarantee for document delivery via the cloud
* Provides clear and consistent pricing
i3CGlobal is a regulatory consulting firm specializing in medical device compliance. They offer expert guidance for manufacturers navigating complex regulatory landscapes.
**Expertise & scope**
* FDA QSR, QMSR, and MDR compliance
* ISO 13485 certification and implementation
* CE marking for medical devices and IVDs
* Technical file and documentation preparation for MDR and IVDR
* Software CE marking and IEC 62304 compliance
* Gap assessments and internal audit programs
* CAPA (Corrective and Preventive Actions) support
* Consulting for drugs, food/food supplements, and cosmetics
**Reputation / proof points**
* Certified with ISO 27001 for data security
* Offers 24/7 uptime guarantee for document delivery via the cloud
* Provides clear and consistent pricing
Additional information
i3CGlobal emphasizes a commitment to data security, holding ISO 27001 certification. They ensure confidentiality and integrity of client information, operating with a 24/7 uptime guarantee for secure cloud-based document delivery. This approach supports a reliable and secure regulatory consulting service. The company also highlights its ability to initiate projects swiftly due to readily available regulatory consulting team manpower, ensuring prompt and efficient commencement and on-time delivery. Their pricing is described as clear and consistent, attracting international clients who value transparency and quality.
Key Highlights
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Specializes in FDA QSR, QMSR, 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.”
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Provides comprehensive support for ISO 13485 certification and CE marking.
Source
“They provide comprehensive support for CE marking, ISO 13485 certification, and quality system implementation.”
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Offers ISO 13485 SOP Templates and procedures for medical devices.
Source
“Get latest ISO 13485 SOP Templates and procedures for medical device from i3cglobal.”
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Certified with ISO 27001 for data security, ensuring confidentiality and integrity.
Source
“Certified with ISO 27001 for data security, we go the extra mile to ensure the confidentiality and integrity of your information.”
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.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA QSR, MDR, and IVDR compliance.
- Companies requiring ISO 13485 certification and implementation support.
- Businesses needing assistance with CE marking and technical documentation.
How engagement typically works
- Project-based consulting for specific regulatory needs.
- Comprehensive support for quality system implementation and documentation.
- On-demand access to regulatory experts.
Typical deliverables
- Regulatory compliance strategies.
- ISO 13485 certified quality management systems.
- Technical files and documentation for CE marking.
- SOP templates and procedures.
- Gap assessments and remediation plans.
Good to know
- Best when clients require specialized regulatory expertise for complex compliance landscapes.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $2,000 - $7,000
Notes:
Pricing estimates are general guides; a comprehensive offer will be provided upon proposal request.
“Below is a comprehensive estimate for the regulatory compliance of the medical device quality management system (MDQMS).”
HQ:
United States, India
Languages:
English
Timezones:
EST, PST
Claim 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
