i3CGlobal (ISO 13485 SOP Templates)
i3CGlobal offers expert medical device regulatory consulting, specializing in MDR/IVDR compliance, CE marking, and technical documentation. They ensure efficient project delivery and data security.
i3CGlobal is a trusted regulatory consulting company and a sustainable partner for medical device manufacturers. They specialize in navigating the complexities of regulatory documentation and registrations with authorities, offering expert services for EU MDR/IVDR, FDA, drugs, food supplements, and cosmetics. With a dedicated team of full-time regulatory experts, i3CGlobal ensures prompt and efficient project commencement and on-time delivery. They are committed to fair and transparent pricing, attracting a global clientele. Their services include comprehensive support for CE Marking, technical file creation, clinical evaluations, risk management, and appointing European Authorized Representatives. Data security is paramount, with ISO 27001 certification ensuring the confidentiality and integrity of client information. i3CGlobal operates 24/7, delivering documents securely via the cloud, providing a reliable and secure regulatory consulting service. They are particularly adept at assisting startups with new medical software and ensuring compliance for importing and marketing devices in Europe.
About
**Who they are**
i3CGlobal (ISO 13485 SOP Templates) is a customer-centric company specializing in regulatory consulting services for healthcare product manufacturers worldwide. They focus on ensuring compliance with EU, USA, and UK regulations.
**Expertise & scope**
* Expertise in Medical Device Regulatory Consulting, including MDR/IVDR compliance, CE marking, and technical documentation.
* Services cover Food, Cosmetic, Drugs, and Medical Device regulatory consulting.
* Support for FDA 510k, QMSR, and ISO 13485 regulatory consulting.
* Specialization in EU Medical Device Regulatory Consulting and USFDA Medical Device Regulatory Consulting.
* Offerings include IVDR CE Marking, IVDR Regulation, IVDR Technical File, IVDR Consultants, IVDR Classification, Software CE Marking, and IVDR PRRC.
* Also provide MDR CE Marking, MDR Classification, Technical File, MDR Consultants, Clinical Evaluation, PMS Report, Risk Management, MDR Article 117, Software CE Marking, Biocompatibility Test, and MDR PRRC.
* Ensure efficient project delivery and data security, with a commitment to honesty, integrity, and fairness.
**Reputation / proof points**
* Recognized as a trustworthy life sciences regulatory consulting company and a sustainable partner.
* Committed to fair pricing and on-time delivery.
* Emphasize data security and cloud documentation.
i3CGlobal (ISO 13485 SOP Templates) is a customer-centric company specializing in regulatory consulting services for healthcare product manufacturers worldwide. They focus on ensuring compliance with EU, USA, and UK regulations.
**Expertise & scope**
* Expertise in Medical Device Regulatory Consulting, including MDR/IVDR compliance, CE marking, and technical documentation.
* Services cover Food, Cosmetic, Drugs, and Medical Device regulatory consulting.
* Support for FDA 510k, QMSR, and ISO 13485 regulatory consulting.
* Specialization in EU Medical Device Regulatory Consulting and USFDA Medical Device Regulatory Consulting.
* Offerings include IVDR CE Marking, IVDR Regulation, IVDR Technical File, IVDR Consultants, IVDR Classification, Software CE Marking, and IVDR PRRC.
* Also provide MDR CE Marking, MDR Classification, Technical File, MDR Consultants, Clinical Evaluation, PMS Report, Risk Management, MDR Article 117, Software CE Marking, Biocompatibility Test, and MDR PRRC.
* Ensure efficient project delivery and data security, with a commitment to honesty, integrity, and fairness.
**Reputation / proof points**
* Recognized as a trustworthy life sciences regulatory consulting company and a sustainable partner.
* Committed to fair pricing and on-time delivery.
* Emphasize data security and cloud documentation.
Additional information
i3CGlobal's services are currently available in English only. They highlight that regulatory documentation and registrations can be complex, resource-intensive, and time-consuming, recommending entrusting these tasks to regulatory experts. The company emphasizes having extra regulatory consulting team manpower ready to initiate projects swiftly, ensuring prompt and efficient commencement and prioritizing on-time delivery. Their clear and consistent pricing attracts customers globally, who value their commitment to fairness, reliability, and a guarantee of quality.
Key Highlights
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Specializes in MDR/IVDR compliance, CE marking, and technical documentation for 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.”
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Provides regulatory consulting services for EU, USA, and UK regulations.
Source
“We ensure compliance with EU, USA, and UK Regulations and provide MDR, IVDR, FDA 510k, CE Marking, QMSR, ISO 13485 regulatory consulting services across the globe.”
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Offers dedicated support for various FDA regulatory consulting needs, including Food, Drugs, and Cosmetics.
Source
“USFDA DRUG Regulatory Consulting; US FDA Food Regulatory Consulting; FDA Cosmetic Regulatory Consulting”
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Emphasizes fair pricing, on-time delivery, and data security.
Source
“FAIR PRICE & ONTIME DELIVERY; DATA SECURITY & CLOUD DOCUMENTATION”
Certifications & Trust Signals
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Recognized as a trustworthy life sciences regulatory consulting company and a sustainable partner.
Source
“making us recognized as the best regulatory consulting company in the industry.”
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Commitment to honesty, integrity, and fairness has earned trust and respect from existing customers.
Source
“At I3CGlobal, we believe in honesty, integrity, and fairness in everything we do.”
Buyer Snapshot
Best for
- Companies seeking medical device regulatory consulting for EU and US markets.
- Manufacturers needing support with MDR and IVDR compliance.
- Businesses requiring assistance with technical documentation and CE marking.
How engagement typically works
- Project-based consulting.
- Focus on on-time delivery.
- Secure cloud-based document management.
Typical deliverables
- Regulatory strategy and documentation.
- CE marking submissions (MDR/IVDR).
- Technical files and dossiers.
- Clinical evaluation reports.
- Risk management files.
- FDA registration support.
Good to know
- Services are currently available in English only.
HQ:
Bengaluru, India
Languages:
English
Timezones:
Asia/Kolkata
Claim status:
Listed
Services & Capabilities
Find Importer & Distributor Compliance Providers | Get Quotes
Jurisdictions:
EU, US
Countries:
IN, DE, FR, US
Industries:
Medical devices, Healthcare, Distribution
Portfolio:
1-5, 6-25
Onboarding time:
6–18 days
Pricing model:
Per SKU
Starting from:
USD 500
Included services:
Importer/Distributor SOP & template pack, Compliance gap scan, Audit readiness support
Training Available:
No
Template Pack Available:
Yes
Deliverables:
SOPs, Templates pack
Role Coverage:
Both
eudamed_onboarding_support
Additional importer_distributor_compliance Details
Role Coverage
importer, distributor, Importer, Distributor, Importer & Distributor
Device Classes Supported
Class I, IIa, IIb, III (implied by MDR/IVDR support)
Supports MDR
Yes
Supports IVDR
Yes
Verification Support
Yes
Storage Conditions Support
No
Onboarding Steps
The website mentions application forms for FDA Food Registration, FDA Drug Registration, FDA Medical Device Registration, Cosmetic Product Listing, and Cosmetic Facility Registration, as well as quote request forms for FDA.
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