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

OEM / ODM Development Process

The OEM and ODM workflows below show the primary activities and deliverables for each stage of development and production introduction.

OEM | BUILD TO PRINT

OEM workflow

For customer-completed product designs, drawings and specifications. PROCH focuses on manufacturability, process establishment, pilot validation and production.

OEM 01

Drawings & Specifications

Review 2D/3D files, material, finish, tolerance, CTQ, inspection criteria and quantity.

OEM 02

DFM & Quotation

Evaluate machining, molding, assembly, tooling, inspection, cost and lead time.

OEM 03

Samples & Process

Build engineering samples and establish process, tooling, SOP and inspection methods.

OEM 04

Customer Approval

Submit samples and documents for appearance, dimension and function confirmation.

OEM 05

Pilot Production

Verify yield, cycle time, process capability, packaging and lot traceability.

OEM 06

Production & Quality

Produce under approved conditions with incoming, in-process and outgoing inspection.

ODM | FROM NEED TO PRODUCT

ODM workflow

For customers with a market need, product concept or functional goal whose design and production specifications are not yet complete.

ODM 01

Product Definition

Clarify intended use, scenario, market, function, appearance, cost and schedule.

ODM 02

Feasibility & Concept

Evaluate architecture, material, process, regulatory risk, supply chain and cost.

ODM 03

Product Engineering

Develop appearance, mechanisms, parts, tolerances, materials, interfaces and DFM/DFA.

ODM 04

Prototype & Verification

Prototype and test function, assembly, reliability and intended conditions.

ODM 05

Design Transfer & Pilot

Transfer drawings, BOM, SOP, tooling, inspection methods and process conditions.

ODM 06

Production Lifecycle

Manage production, traceability, engineering change, complaints, CAPA and improvement.

Core Capabilities

Reducing Production Risks Before Product Development

01

Move Engineering Decisions Forward

Confirm materials, structure, tolerances, assembly methods, inspection conditions and primary risks before tooling and production investment.

Product DFM Analysis →
02

Align Design and Manufacturing

Include process, tooling, inspection and supply-chain conditions during design to reduce late changes and rework.

Explore Design Capabilities →
03

Connect Development to Production

Connect prototypes, verification, design transfer, pilot production, assembly and production through one consistent engineering framework.

View Development Process →
04

Quality & Traceability Management

Manage documents, materials, processes, inspection, changes and corrective-action records under ISO 13485.

Explore Quality & Inspection →