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

**Who they are**
Kehu-Morlab (Tianjin) Electronic Technology Co., Ltd. is a provider specializing in Electrical Safety and EMC Testing, particularly for medical devices under standards like IEC 60601.

**Expertise & scope**
* Electrical Safety Testing (IEC 60601 series)
* Electromagnetic Compatibility (EMC) Testing (IEC 60601 series)
* Testing for other standards including IEC 61010-1 and ISO/IEC 17025 accreditation.

**Reputation / proof points**
* Accredited to ISO/IEC 17025, indicating adherence to international standards for testing and calibration laboratories.

Additional information

Kehu-Morlab (Tianjin) Electronic Technology Co., Ltd. focuses on providing comprehensive testing services to ensure product compliance with international safety and EMC regulations. Their expertise in the IEC 60601 series is crucial for medical device manufacturers seeking market access. Buyers can expect a structured testing process aimed at identifying and resolving potential compliance issues early in the development cycle. Engagement typically involves submitting product samples for rigorous testing against specified standards.

Key Highlights

  • Specializes in Electrical Safety + EMC Testing for IEC 60601 standards. Source
    “Electrical Safety + EMC Testing (IEC 60601)”
  • Accredited to ISO/IEC 17025, ensuring testing competence. Source
    “ISO/IEC 17025”
  • Supports testing for IEC 61010-1 standards. Source
    “IEC 61010-1”

Certifications & Trust Signals

  • ISO/IEC 17025 accredited laboratory. Source
    “ISO/IEC 17025”

Buyer Snapshot

Best for
  • Medical device manufacturers requiring IEC 60601 testing
  • Companies needing electrical safety and EMC compliance validation
How engagement typically works
  • Project-based testing engagements
  • Direct collaboration on compliance requirements
Typical deliverables
  • Test reports for safety and EMC compliance
  • Certification support documentation
Good to know
  • Best when specific product samples are available for testing.
HQ: Tianjin, China
Languages: English
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

Additional medical_device_emc_testing Details

Standards Supported
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 61010-1, ISO/IEC 17025
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
Request quotes
Cruxi - Regulatory Compliance Services