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 customer-centric company specializing in regulatory consulting services for medical device, food, cosmetic, and drug manufacturers worldwide. They focus on ensuring compliance with EU, USA, and UK regulations.
**Expertise & scope**
* FDA QSR (QMSR) compliance and transition support
* ISO 13485 certification and implementation
* Medical Device Quality Management System (MDQMS) development
* EU MDR and IVDR CE Marking, including technical files and classification
* Software as a Medical Device (SaMD) regulatory consulting
* Risk management and CAPA (Corrective and Preventive Actions)
* Post-Market Surveillance (PMS) reporting
* Data security and cloud-based documentation management
**Reputation / proof points**
* Certified with ISO 27001 for data security
* Demonstrated experience with QMSR, ISO 13485, IEC 62304, MDR, and IVDR through case studies
i3CGlobal is a customer-centric company specializing in regulatory consulting services for medical device, food, cosmetic, and drug manufacturers worldwide. They focus on ensuring compliance with EU, USA, and UK regulations.
**Expertise & scope**
* FDA QSR (QMSR) compliance and transition support
* ISO 13485 certification and implementation
* Medical Device Quality Management System (MDQMS) development
* EU MDR and IVDR CE Marking, including technical files and classification
* Software as a Medical Device (SaMD) regulatory consulting
* Risk management and CAPA (Corrective and Preventive Actions)
* Post-Market Surveillance (PMS) reporting
* Data security and cloud-based documentation management
**Reputation / proof points**
* Certified with ISO 27001 for data security
* Demonstrated experience with QMSR, ISO 13485, IEC 62304, MDR, and IVDR through case studies
Additional information
i3CGlobal emphasizes a commitment to honesty, integrity, and fairness, aiming to be a sustainable partner for life sciences manufacturers. They highlight their ability to initiate projects swiftly with a dedicated team of full-time regulatory experts, prioritizing on-time delivery. The company offers clear and consistent pricing, with a guarantee of quality. Their operational model includes 24/7 uptime for secure document delivery via the cloud, ensuring confidentiality and integrity of client information.
Key Highlights
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Specializes in FDA QSR (QMSR) transition and inspection readiness.
Source
“i3CGlobal is a dynamic and customer centric company specializing in delivering Food, Cosmetic, Drugs, and Medical Device Regulatory Consulting Services”
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Offers comprehensive support for ISO 13485 certification and implementation.
Source
“ISO 13485 Certification is very important for medical device companies, as it helps them show that they are following all required regulatory standards”
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Provides expertise in EU MDR and IVDR CE Marking processes.
Source
“IVDR CE MARKING MDR CE MARKING”
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Certified with ISO 27001 for data security, ensuring confidentiality and integrity of client information.
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”
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA QMSR transition and inspection readiness.
- Companies requiring assistance with ISO 13485 certification and implementation.
- Businesses needing support for EU MDR and IVDR CE marking processes.
How engagement typically works
- Project-based consulting
- On-demand expert support
Typical deliverables
- Regulatory compliance strategies
- Quality Management System documentation (SOPs, procedures)
- Technical files and regulatory submissions
- Audit readiness support
- CAPA and risk management plans
Good to know
- Best when requiring specialized regulatory expertise for complex compliance landscapes.
Pricing
Model:
Custom pricing
Public range:
Publicly listed: $50.00 - $7,000+
Notes:
Pricing varies based on project scope and specific services required, such as ISO 13485 implementation, auditing, or software compliance.
“$ 2000; $ 3000; $7000; $ 3000”
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
