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Product Quality

Quality starts at the concept stage and continues through prototype testing, manufacturing and compliance

ISO 13485 BSI certification
FDA
CE  mark
HSA
FCC
UL
ROHS
CCC

Documentation for compliance

  • Design History File (DHF)

  • Risk Management

  • Test plan and results

A systematic approach to compliance

At any stage of your product development, we embed quality in our work.

From our internal laboratory, Lab79, in Singapore to our ISO 13485 certified processes, we ensure that your product compliance, reliability and functions are at the utmost.

Idea or

Lab proto

Functional

Prototype

Production

Qualified

Innovation & Design

Engineering

Development

Manufacturing

Transfer to Production

Design

verified

Quality &

Processes

Group 1
Group 2
Group 3
LAB79 – your pre-certification insurance
Testing lab

Our testing equipment is situated near our engineers, in Singapore, where we perform all kind of tests from early modules assessment to pre-certification tests

Certifications

We are certified to meet international quality standards, ensuring compliance and reliability for global markets.

BSI
SME 500 Singapore
President award
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