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Product Development Services

Contract Manufacturing Services

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Risk Management

Risk management plan
Risk assessment FMEA
Risk control
Evaluation of overall risk acceptability
Risk management report

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Concept Design

Defining the intended purpose of the device based on user needs and clinical requirements
Device functional diagrams, materials and technology options
Market analysis, intellectual property studies and feasibility studies with technical and economic assessments
Regulatory compliance and standards identification
Design control and establishment of DHF

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Product Engineering

Mechanical design in 3D modelling with CAD software
Tolerance and mold flow analysis with CAE software
DFM and DFA analysis
Evaluation of materials selection

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Design Verification with Prototype

Various prototyping options such as 3D printing, CNC, and silicone vacuum forming
Functional tests and usability studies
DFMEA review and design output
Production and assembly process studies with PFMEA

Mold and Automation Fabrication

High precision mold with minimum of 1 million shots with consistent quality
Mold certification process to prove the molds are qualified and consistent
Process validation with IQ, OQ and PQ