i3cglobal
i3cglobal: Expert FDA 510(k) & Regulatory Strategy Consulting for Medical Devices
i3cglobal is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. They possess deep expertise in navigating complex regulatory pathways, with a strong focus on 510(k) submissions and developing robust regulatory strategies. Their services extend to comprehensive support for quality management systems and international regulatory compliance, including EU MDR/IVDR and UKCA.
About
i3cglobal is a dedicated FDA regulatory consulting firm specializing in supporting medical device companies. They possess deep expertise in navigating complex regulatory pathways, with a strong focus on 510(k) submissions and developing robust regulatory strategies. Their services extend to comprehensive support for quality management systems and international regulatory compliance, including EU MDR/IVDR and UKCA.
Additional information
### **Additional information**
- **Type:** independent
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Location:** GB
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This consultant specializes in FDA 510(k) submissions for medical devices and IVDs. They provide services to help navigate the regulatory pathway. Their LinkedIn presence suggests a broader scope of services beyond just 510(k) consulting.
- **Unique value:** Specializes in FDA 510(k) submissions for medical devices and IVDs.
- **Ideal projects:** A medical device or IVD company seeking assistance with FDA 510(k) submissions. This could include companies needing help with regulatory strategy, submission preparation, or navigating the FDA process.
- **Confidence score:** 50/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pre-submission, annual_reports
- **Specialties:** regulatory strategy, quality management systems, risk management
- **Device panels:** general_surgery, cardiovascular, neurology, orthopedic, gastroenterology, urology
- **Regulatory pathways:** 510k, de_novo, pre-submission, ide
- **Type:** independent
- **Years of experience:** 7
- **510(k)s submitted (self-reported):** 15
- **Location:** GB
- **Availability:** available_now
### **Cruxi analysis**
- **Strength summary:** This consultant specializes in FDA 510(k) submissions for medical devices and IVDs. They provide services to help navigate the regulatory pathway. Their LinkedIn presence suggests a broader scope of services beyond just 510(k) consulting.
- **Unique value:** Specializes in FDA 510(k) submissions for medical devices and IVDs.
- **Ideal projects:** A medical device or IVD company seeking assistance with FDA 510(k) submissions. This could include companies needing help with regulatory strategy, submission preparation, or navigating the FDA process.
- **Confidence score:** 50/100
### **Qualifications & scope**
- **Submission types:** 510k-traditional, 510k-special, pre-submission, annual_reports
- **Specialties:** regulatory strategy, quality management systems, risk management
- **Device panels:** general_surgery, cardiovascular, neurology, orthopedic, gastroenterology, urology
- **Regulatory pathways:** 510k, de_novo, pre-submission, ide
Key Highlights
- This consultant specializes in FDA 510(k) submissions for medical devices and IVDs. They provide services to help navigate the regulatory pathway. Their LinkedIn presence suggests a broader scope of services beyond just 510(k) consulting.
- Specializes in FDA 510(k) submissions for medical devices and IVDs.
Certifications & Trust Signals
- 7 years experience
- 15 510(k)s submitted (self-reported)
Buyer Snapshot
Best for
- A medical device or IVD company seeking assistance with FDA 510(k) submissions. This could include companies needing help with regulatory strategy, submission preparation, or navigating the FDA process.
HQ:
GB
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
510(k) Strategy & Authoring, 510(k) eSTAR Preparation, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, Regulatory Pathway Assessment, Device Classification Support, Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA, Pre-Sub / Q-Sub
Device Types Supported:
Medical device, IVD, SaMD
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
7
Num510k Submitted:
15
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
general_surgery, cardiovascular, neurology, orthopedic, gastroenterology, urology
Accepting New Clients:
Yes
Supports Estar:
Yes
Supports Labeling Review:
No
Provides Submission Project Management:
Yes
Engagement Models:
Consulting
