Regulatory&QA

MOKOMEDTECH is fully certified and complies with regulations, we provide regulatory services to help our clients bring new products to their target markets.

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Understand the intended use of the customer’s medical device and then conduct a regulatory assessment to determine product classification. Be prepared in advance by communicating with relevant agencies to clarify the regulatory requirements in this area.

According to the relevant regulatory requirements, we will work with your team to review, prepare and submit all the documents required for preparation, to effectively address regulatory issues and minimize additional issues.

Following regulatory filings, we continue to provide relevant support throughout the product lifecycle to ensure the flexibility of our products and services.

With Our Expertise, We Can Guide You Through:

CE marking
FDA regulatory strategy
FDA device Classification
US FDA 510(k) preparation
UDI compliance consulting
Medical Device Risk Management certifications
RoHS Certification
IEC 60601 Certification
ISO 13485 Implementation & Certification
Technical File/Dossier File/Medical Device File

Quality Assurance

High-quality Raw Materials

Medical electronic devices must be manufactured to the highest standards, and raw materials are the first step. We only work with certified material suppliers to ensure that all materials they supply can meet industry standards.

Professional Cleanroom Manufacturing

We manufacture medical electronics in the cleanroom, which helps improve product quality as the environment has only little impact on the product. Moreover, we perform daily disinfection for the cleanroom to ensure its cleanliness.

Stringent Quality Control System

MOKOMEDTECH never compromises on quality, our stringent quality control system ensures that each product we manufacture is of high quality. We are certified with ISO 13485:2016, BSCI, UL, ISO 9001, and ISO 14001.

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