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.
Buyer Snapshot
Best for
- Medical device manufacturers seeking FDA 510(k) and other regulatory pathway support.
- Companies requiring assistance with EU MDR/IVDR compliance.
- Businesses prioritizing data security and cloud-based documentation.
How engagement typically works
- Project-based consulting.
- Focus on swift project initiation and on-time delivery.
- Transparent and fair pricing.
Typical deliverables
- FDA 510(k) submissions (Traditional, eSTAR, RTA remediation).
- De Novo submissions.
- Regulatory strategy documents.
- Technical files for MDR/IVDR.
- Registration and listing support.
Good to know
- Best when requiring services primarily in English.
- Best when seeking support for US FDA and EU regulations.
Pricing
Model:
Per project
Public range:
Publicly listed: $33,116 - $132,464
Notes:
Based on publicly listed information for De Novo submissions; final fees depend on scope.
“Pricing: $132,464; $33,116”
HQ:
GB
Languages:
English
Timezones:
UTC, EST
Claim status:
Listed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) eSTAR Preparation, Predicate Research & Substantial Equivalence Strategy, 510(k) RTA Remediation / Refuse-to-Accept Fix, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C), Submission Project Management (end-to-end)
Pathways Supported:
Traditional 510(k), Special 510(k), Abbreviated 510(k), De Novo, PMA
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
