Kumo Compliance Advisors
Cruxi Inc.
Cruxi offers AI-powered regulatory submission services for medical devices, simplifying FDA 510(k), De Novo, and PMA processes with expert guidance and automated compliance checks.
Cruxi provides a comprehensive, AI-powered platform designed to streamline medical device regulatory submissions. They offer 14 distinct services covering both FDA and global market requirements, including FDA 510(k) submissions, De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. Their intelligent automation, automated compliance checks, and expert guidance aim to simplify complex regulatory pathways from device classification to final submission. For novel, low to moderate-risk devices, Cruxi supports the mandatory eSTAR use for De Novo submissions. They also facilitate formal device classification determinations and offer 180-day, Real-Time supplements with repeatable templates and checklists. The platform is built to handle all your regulatory needs within a single, intelligent system, ensuring efficiency and compliance at every step.
About
**Who they are**
Kumo Compliance Advisors is a specialized firm focused on regulatory compliance for the Japanese market. They provide expert guidance to navigate the complexities of Japan's regulatory landscape.
**Expertise & scope**
* Expertise in Japanese MAH/DMAH requirements.
* Support for regulatory submissions and compliance.
* Services available in Japanese, English, and Chinese.
**Reputation / proof points**
* Coverage focused on Japan (JP).
Kumo Compliance Advisors is a specialized firm focused on regulatory compliance for the Japanese market. They provide expert guidance to navigate the complexities of Japan's regulatory landscape.
**Expertise & scope**
* Expertise in Japanese MAH/DMAH requirements.
* Support for regulatory submissions and compliance.
* Services available in Japanese, English, and Chinese.
**Reputation / proof points**
* Coverage focused on Japan (JP).
Additional information
Engaging Kumo Compliance Advisors involves leveraging their specific expertise in Japanese regulations. Buyers can expect support tailored to the unique requirements of the Japanese market, facilitating smoother entry and ongoing compliance. Their multilingual capabilities are a key asset for international companies operating in Japan.
Key Highlights
Certifications & Trust Signals
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Coverage exclusively for Japan (JP).
Source
“Cruxi offers AI-powered regulatory submission services for medical devices, simplifying FDA 510(k), De Novo, and PMA processes with expert guidance and automated compliance checks.”
Buyer Snapshot
Best for
- Companies seeking to comply with Japanese medical device regulations.
- Businesses requiring MAH/DMAH services in Japan.
- International firms needing local regulatory expertise.
How engagement typically works
- Consultative approach to regulatory challenges.
- Direct support for submission processes.
Typical deliverables
- Regulatory strategy development for Japan.
- Submission dossier preparation and filing.
- Ongoing compliance support.
Good to know
- Best when focused on the Japanese market.
HQ:
Kyoto, US
Languages:
Japanese, English, Chinese
Timezones:
Asia/Tokyo
Status:
listed
Services & Capabilities
Japan MAH / DMAH Services
Jurisdictions:
JP
Countries:
JP
Industries:
Medical devices, IVD, Life sciences
Portfolio:
6-25
Onboarding time:
10–45 days
Pricing model:
Per project
Starting from:
USD 8,500
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
Onboarding typically involves an initial consultation to define the scope of services and gather necessary technical and quality documentation.
Service Notes
This seed profile is unverified and intended for initial directory population.
Offers MAH
Yes
Offers DMAH
Yes
PMDA Support
Yes
Regulatory Liaison PMDA
Yes
Translation Support
Yes
