Kizuna MedTech Partners
Kizuna MedTech Partners offers AI-powered regulatory submission services for medical devices, streamlining processes from FDA 510(k) to De Novo and PMA.
Kizuna MedTech Partners provides a comprehensive suite of AI-powered regulatory services designed to streamline medical device submissions. Their platform covers a wide range of needs, including FDA 510(k), De Novo Classification Requests (eSTAR), Q-Submissions (Pre-Sub), 513(g) Requests, PMA Supplements, Humanitarian Device Exemptions (HDE), and IDE Submissions. Leveraging intelligent automation and expert guidance, Kizuna MedTech Partners aims to simplify complex regulatory pathways. They offer solutions for both FDA and global markets, ensuring compliance and efficiency at every stage of the submission process. Their services are built on an intelligent platform that includes automated compliance checks and expert support. For traditional 510(k) submissions, they manage the complete workflow from device classification to the final submission package, targeting the standard 90-day FDA review. They also support novel, low to moderate-risk devices, with a focus on the upcoming eSTAR mandate. Additionally, they facilitate formal device classification determinations and offer support for 180-day, Real-Time supplements with repeatable templates and checklists.
About
**Who they are**
Kizuna MedTech Partners is a firm specializing in AI-powered regulatory submission services for medical devices. They focus on streamlining the complex processes involved in bringing medical devices to market.
**Expertise & scope**
* AI-powered regulatory submission services
* Expertise in FDA 510(k) submissions
* Experience with De Novo applications
* Proficiency in Premarket Approval (PMA) processes
* Coverage for the Japanese market (JP)
**Reputation / proof points**
* Languages supported: Japanese, English, Chinese, Korean
Kizuna MedTech Partners is a firm specializing in AI-powered regulatory submission services for medical devices. They focus on streamlining the complex processes involved in bringing medical devices to market.
**Expertise & scope**
* AI-powered regulatory submission services
* Expertise in FDA 510(k) submissions
* Experience with De Novo applications
* Proficiency in Premarket Approval (PMA) processes
* Coverage for the Japanese market (JP)
**Reputation / proof points**
* Languages supported: Japanese, English, Chinese, Korean
Additional information
Kizuna MedTech Partners leverages AI to accelerate regulatory submissions for medical devices. Their services are designed to navigate the intricacies of pathways such as FDA 510(k), De Novo, and PMA. The firm's multilingual capabilities, including Japanese, English, Chinese, and Korean, facilitate communication and documentation across diverse regulatory environments. Their focus on the Japanese market (JP) indicates a specialized understanding of regional requirements. Buyers engaging Kizuna MedTech Partners can expect a technology-driven approach to compliance, aiming for efficiency and accuracy in the submission lifecycle.
Key Highlights
-
Offers AI-powered regulatory submission services for medical devices.
Source
“Kizuna MedTech Partners offers AI-powered regulatory submission services for medical devices”
-
Expertise spans FDA 510(k), De Novo, and PMA submissions.
Source
“streamlining processes from FDA 510(k) to De Novo and PMA.”
-
Provides coverage for Japan (JP).
Source
“Coverage: JP”
-
Supports multiple languages including Japanese, English, Chinese, and Korean.
Source
“Languages: Japanese, English, Chinese, Korean”
Certifications & Trust Signals
-
Focus on regulatory submissions for medical devices.
Source
“Kizuna MedTech Partners offers AI-powered regulatory submission services for medical devices”
Buyer Snapshot
Best for
- Medical device companies seeking AI-driven regulatory submission support
- Firms targeting the Japanese market
- Companies needing assistance with FDA 510(k), De Novo, or PMA applications
How engagement typically works
- Project-based submission support
- Technology-enabled process streamlining
Typical deliverables
- Completed regulatory submission packages
- Streamlined submission processes
- AI-generated insights for submissions
Good to know
- Best when requiring specialized support for FDA pathways and Japanese market entry.
HQ:
Nagoya, Japan
Languages:
Japanese, English, Chinese, Korean
Timezones:
Asia/Tokyo
Status:
listed
Services & Capabilities
Japan MAH / DMAH Services
Jurisdictions:
JP
Countries:
JP
Industries:
Medical devices, IVD, Life sciences
Portfolio:
26-100
Onboarding time:
7–30 days
Pricing model:
Onboarding + annual retainer
Starting from:
USD 12,000
Included services:
MAH/DMAH appointment support, PMDA liaison and communications routing, Local license/establishment maintenance support, Translation enablement (scope-dependent), GMP/QMS coordination support (scope-dependent)
Offers MAH:
Yes
Offers DMAH:
Yes
PMDA Support:
Yes
Languages:
Japanese
Local License Capability:
Yes
Translation Support:
Yes
GMP Qmssupport:
Yes
Regulatory Liaison PMDA:
Yes
Additional jp_mah_dmah Details
Included Services Detailed
MAH/DMAH onboarding and mandate setup (seed scope), PMDA liaison and communications routing (seed scope), Local license/establishment maintenance tasks (seed scope), Translation enablement for core regulatory documents (seed scope), GMP/QMS coordination support for audit readiness (seed scope)
Excluded Services
Manufacturing or supply chain execution, Acting as commercial distributor by default, Legal representation in disputes or litigation
Onboarding Steps
Intake → scope & product mapping → mandate & responsibility matrix → workflow setup → PMDA liaison cadence
Service Notes
This seed profile is unverified and intended for initial directory population.
Offers MAH
No
Offers DMAH
No
PMDA Support
No
Regulatory Liaison PMDA
No
Translation Support
Yes
