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 regulatory consulting company specializing in medical device compliance. They offer expert services to navigate complex regulatory documentation and registrations.
**Expertise & scope**
* Medical Device Regulatory Consulting (EU & US)
* MDR / IVDR Compliance
* CE Marking
* Technical Documentation / Technical File preparation
* Clinical Evaluation
* Post-Market Surveillance (PMS) Reports
* Risk Management
* Software CE Marking
* Biocompatibility Testing
* Regulatory PRRC (Person Responsible for Regulatory Compliance)
* FDA Registrations (Medical Device, Drug, Food)
* Cosmetic Product Listing and Facility Registration
* Consulting for Drugs, Food/Food Supplements, and Cosmetics
**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Services are currently available in English only.
i3CGlobal (ISO 13485 SOP Templates) is a regulatory consulting company specializing in medical device compliance. They offer expert services to navigate complex regulatory documentation and registrations.
**Expertise & scope**
* Medical Device Regulatory Consulting (EU & US)
* MDR / IVDR Compliance
* CE Marking
* Technical Documentation / Technical File preparation
* Clinical Evaluation
* Post-Market Surveillance (PMS) Reports
* Risk Management
* Software CE Marking
* Biocompatibility Testing
* Regulatory PRRC (Person Responsible for Regulatory Compliance)
* FDA Registrations (Medical Device, Drug, Food)
* Cosmetic Product Listing and Facility Registration
* Consulting for Drugs, Food/Food Supplements, and Cosmetics
**Reputation / proof points**
* Certified with ISO 27001 for data security.
* Services are currently available in English only.
Additional information
i3CGlobal emphasizes efficient project delivery and data security, operating with a 24/7 uptime guarantee and delivering documents securely via the cloud. They highlight their commitment to fair and transparent pricing, attracting a global clientele. The company is equipped to initiate projects swiftly with dedicated full-time regulatory experts, ensuring prompt and efficient commencement. They also provide application forms for FDA registrations and cosmetic product listings, as well as quote request forms.
Key Highlights
-
Specializes in MDR/IVDR compliance, CE marking, and technical documentation for medical devices.
Source
“i3CGlobal offers expert medical device regulatory consulting, specializing in MDR/IVDR compliance, CE marking, and technical documentation.”
-
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.”
-
Provides regulatory consulting services for both EU and US markets.
Source
“Coverage: EU, US”
-
Offers 24/7 uptime guarantee for secure cloud-based document delivery.
Source
“Operating around the clock with a 24/7 uptime guarantee, we diligently work, maintain, and securely deliver documents via the cloud”
Certifications & Trust Signals
-
Certified with ISO 27001 for data security.
Source
“Certified with ISO 27001 for data security”
Buyer Snapshot
Best for
- Medical device manufacturers seeking MDR/IVDR compliance
- Companies needing CE marking and technical documentation support
- Businesses requiring regulatory consulting for EU and US markets
How engagement typically works
- Project-based consulting
- Focus on on-time delivery
- Secure cloud-based document management
Typical deliverables
- MDR/IVDR Technical Files
- CE Marking documentation
- Regulatory registration support
- Clinical Evaluation Reports
- Risk Management documentation
Good to know
- Services are currently available in English only.
HQ:
Bengaluru, India
Languages:
English
Timezones:
Asia/Kolkata
Status:
listed
Services & Capabilities
Importer & Distributor Compliance Support
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
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 "initiate any project swiftly" and "prompt and efficient commencement", suggesting a focus on quick project starts, but does not detail specific onboarding steps or required documents.
