Kehu-Morlab (Tianjin) Electronic Technology Co., Ltd.
Cruxi offers AI-powered regulatory submission services for medical devices, including FDA 510(k), De Novo, and PMA. They streamline compliance with expert guidance and automated checks.
Cruxi provides a comprehensive AI-powered regulatory platform designed to simplify medical device submissions for FDA and global markets. Their services cover the entire regulatory process, from device classification to final submission packages, utilizing intelligent automation and automated compliance checks. Key offerings include FDA 510(k) submissions, De Novo Classification Requests (eSTAR), Q-Submissions, and PMA Supplements. They also support 513(g) Requests and Humanitarian Device Exemptions (HDE). Cruxi aims to provide expert guidance and efficient workflows, making regulatory compliance more accessible for medical device manufacturers. The platform is built to handle various submission types, including traditional 510(k)s with a 90-day FDA review target, and supports the mandatory eSTAR use for De Novo submissions starting October 1, 2025. Their approach combines structured questioning, meeting requests, and briefing book preparation to ensure a smooth submission process.
About
Kehu-Morlab (Tianjin) Electronic Technology Co., Ltd. is a provider focused on Electrical Safety and EMC Testing, specifically referencing IEC 60601 standards. Their services are geared towards ensuring medical devices meet rigorous safety and electromagnetic compatibility requirements.
- **Expertise & Scope**
* Electrical Safety Testing (IEC 60601 series)
* EMC Testing (IEC 60601 series)
* Compliance testing for medical devices
- **Reputation / Proof Points**
* Accredited to ISO/IEC 17025
- **Expertise & Scope**
* Electrical Safety Testing (IEC 60601 series)
* EMC Testing (IEC 60601 series)
* Compliance testing for medical devices
- **Reputation / Proof Points**
* Accredited to ISO/IEC 17025
Additional information
For buyers seeking Electrical Safety and EMC Testing under the IEC 60601 series, Kehu-Morlab (Tianjin) Electronic Technology Co., Ltd. provides testing services to help ensure product compliance. Engagement typically involves submitting product samples for testing against specified standards. Deliverables usually include test reports that can be used for regulatory submissions. Buyers should be prepared to provide detailed product information and specifications to facilitate the testing process.
Key Highlights
Certifications & Trust Signals
-
Accredited to ISO/IEC 17025.
Source
“ISO/IEC 17025”
Buyer Snapshot
Best for
- Medical device manufacturers requiring IEC 60601 compliance testing
- Companies needing Electrical Safety and EMC testing services
How engagement typically works
- Project-based testing
- Submission of product samples for evaluation
Typical deliverables
- Electrical Safety Test Reports
- EMC Test Reports
Good to know
- Best when detailed product specifications and samples are readily available.
HQ:
Tianjin, China
Languages:
English
Claim status:
Listed
Services & Capabilities
Electrical Safety + EMC Testing (IEC 60601)
Industries:
Medical Devices
Pricing model:
Custom pricing
Standards Supported:
IEC 60601-1-2
Test Coverage:
EMC only
Regions Served:
FDA, global markets
Nda Support:
Yes
Nrtl Relationships:
Other
Max Eut Size:
Custom
Chamber Type:
Other
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Sample Return Policy:
Return
Additional medical_device_emc_testing Details
Standards Supported
IEC 60601
Test Coverage
Both
Nrtl Relationships
Other
Max Eut Size
Custom
Chamber Type
Other
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Test Types Offered
Electrical Safety, EMC
Sample Return Policy
Return
Minimum Project Size
Custom
Pricing Model
Per project
