MEDICAL DEVICE PRODUCT DEVELOPMENT | ISO 13485 QUALITY SYSTEM | OEM / ODM
About PROCH

Integrated Design, Verification and Production

PROCH focuses on the development, production and assembly of metal and plastic components for portable medical devices. From requirement confirmation and engineering design through production introduction, we provide a consistent and traceable product-realization process.

ISO 13485 + ISO 9001Medical device and quality management systems
OEM / ODMEngagement models aligned with project maturity
Plastic / CNC / AssemblyIntegrated plastic, metal and assembly processes
SINCE 1999Product development and manufacturing experience
Quality Certification

Quality System Certification

PROCH manufacturing operations are supported by ISO 9001 and ISO 13485 quality management systems across medical components, precision CNC machining, plastic injection molding, assembly and related manufacturing services.

PROCH ISO 9001 quality management system certificate

ISO 9001

Quality management system

PROCH ISO 13485 medical device quality management system certificate

ISO 13485

Medical device quality management system

Company History

Development Milestones

1999

Established the tooling department and built product development and manufacturing capabilities.

2001

Established the injection molding department and supported component development and production for notebook system manufacturers.

2002

Completed tooling development and injection molding projects for Nichia LED video-wall products.

2004

Surface treatment and coating capabilities were approved by HTC.

2009

Provided one-stop tooling, injection molding and product coating services for Moshi protective cases, and tooling and injection molding services for Black+Blum food-grade containers.

2010

Expanded into biotechnology and medical device related product projects.

2011

Expanded into the design and manufacture of smartphone and tablet accessories.

2014

Established the product R&D team.

2015

Began manufacturing LED lighting products.

2018

Undertook the design and development of consumer products for HARIO.

2020

Launched and began sales of our own-brand coffee scale featuring a retractable display protection design.

2022

Achieved ISO 13485 certification for the medical device quality management system.

2023

Officially launched our own-brand coffee grinder.

2025

Introduced digital approval and document control systems to digitalize document management and internal workflows, improving information traceability and management efficiency.

2026

Established an AI-assisted quality audit platform to support quality record review and anomaly identification, improving quality management and traceability efficiency.

What We Offer

What We Offer

Requirement Research & Feasibility

Clarify intended use, use scenarios, functional requirements, materials and process conditions to establish an actionable development direction.

Product & Mechanical Design

Integrate appearance, structure, materials, tolerances and assembly interfaces with DFM/DFA to improve production feasibility.

Prototyping & Engineering Verification

Use rapid prototypes, functional testing and assembly review to confirm design performance and reduce engineering risk before production.

Contract Manufacturing & Component Processing

Integrate CNC machining, plastic injection molding and metal/plastic component processing under approved drawings and specifications.

Assembly & Process Integration

Plan assembly sequence, fixtures, mistake-proofing and work standards for pilot production, production and lot traceability.

Quality Inspection & Traceability

Perform incoming, first article, in-process and outgoing inspection against drawings, tolerances and CTQs, retaining required measurement and lot records.