Production Set Up & Tooling

At production set-up and tooling phase, activity is dedicated to develop a singular design for production – with costings (non-recurring engineering (NRE) costs), processes and vendors, tooling, testing/simulation, specifications and documentation including packaging, sterilisation and test methods all considered.

Our in-house production set-up team allows us to deliver on our promise of efficient early product development following design approval. We strive to achieve shorter lead times and reduce risk by the co-ordinated supervision of the production of tooling and equipment. Product is made ready to transfer to manufacturing phase with production elements put in place for a successful product launch and production ramp up. Key deliverables for the production set-up and tooling phase includes the release to tooling, tooling completion and the completion of design verification testing.

medical device product development

Key Capabilities Employed:

Mouldflow Analysis
Work Instruction Creation
Documentation Build – Bill of Materials (BOM), Work Instructions (WI), Drawings,Test Protocols
Tolerance Analysis
Critical Dimension Review
Initial Sample Inspection
Process Failure Mode Effect Analysis (PFMEA)
Release Specification Pack – ISO 13485
Tool Design and Build
Printing and Packaging Tools
Jigs and Fixtures Build
Test Equipment Build
Production Transfer
Pilot Build and Test

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