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 specializing in Electrical Safety and EMC Testing, with a focus on standards such as IEC 60601. They offer testing services to help manufacturers ensure their products meet regulatory requirements for market access.
- **Expertise & Scope**
* Electrical Safety Testing (IEC 60601 series)
* Electromagnetic Compatibility (EMC) Testing
* Compliance testing for medical devices
- **Reputation / Proof Points**
* Accredited testing laboratory
- **Expertise & Scope**
* Electrical Safety Testing (IEC 60601 series)
* Electromagnetic Compatibility (EMC) Testing
* Compliance testing for medical devices
- **Reputation / Proof Points**
* Accredited testing laboratory
Additional information
Manufacturers engaging Kehu-Morlab (Tianjin) Electronic Technology Co., Ltd. for Electrical Safety and EMC Testing should be prepared to provide detailed product documentation, including schematics and user manuals, to facilitate the testing process. The typical engagement involves initial consultation to define the scope of testing based on target markets and applicable standards, followed by sample submission for laboratory evaluation. Deliverables usually include comprehensive test reports that can be used for regulatory submissions.
Key Highlights
Certifications & Trust Signals
-
Accredited testing laboratory.
Source
“Accredited testing laboratory”
Buyer Snapshot
Best for
- Manufacturers seeking Electrical Safety and EMC testing for medical devices.
- Companies needing to comply with IEC 60601 standards.
How engagement typically works
- Consultation to define scope.
- Sample submission for testing.
- Provision of test reports.
Typical deliverables
- Electrical Safety Test Reports.
- EMC Test Reports.
- Compliance documentation.
Good to know
- Best when product documentation is readily available.
- Requires submission of product samples for testing.
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
