Medical Manufacturing
Custom Fixture Design
Prauna's custom fixture design service delivers end-to-end engineering — from initial concept or customer drawing through 3D modelling, DFM analysis, CNC manufacture, and CMM-validated delivery. Whether you have a detailed 2D drawing, a 3D model, or only a sample part, our engineering team will design and build a fixture that meets your production tolerance, throughput, and quality requirements.
Key Features
Service Specifications
Service Description
Prauna's custom fixture design capability spans the full spectrum from simple single-operation holders to multi-station modular fixture systems for high-volume medical device lines. Our engineers are experienced in the unique demands of medical manufacturing — tight tolerances, cleanroom compatibility, traceability, and the regulatory documentation required for ISO 13485 quality systems.
We start every project with a process review meeting to understand not only the part geometry but the production context: machine type, cycle time targets, operator skill level, cleanroom class, and inspection requirements. This front-end investment in understanding ensures the fixture we design is optimised for your real production environment, not just the drawing.
All design work is performed in SolidWorks with full parametric modelling — allowing rapid revision during the review stage. Customers receive a complete design package including 3D model, manufacturing drawings, BOM, and DFM report, all in formats compatible with your own CAD/PLM systems.
Typical Design Projects
🏥 First-Time Tooling
Complete fixture design for new medical device components entering production
🔄 Legacy Redesign
Redesign of worn, poorly-performing, or non-compliant legacy fixtures
📦 Product Family Fixtures
Modular fixture families to handle multiple variants from a common base design
🤖 Automation Integration
Fixtures designed for robot-loaded cells, conveyor systems, and automated inspection
🔬 Inspection Fixtures
Dedicated CMM and vision inspection fixtures with datum-registered part nesting
🌡️ Environmental Test Rigs
Thermal cycling, vibration, and fatigue test fixtures for medical device validation
Our Design Process
Brief & Inputs
Receive drawings, samples, and process requirements
Concept Design
2–3 concept options with pros/cons for customer selection
Detailed 3D Design
Full parametric 3D model with tolerances and GD&T
Design Review
Virtual design review meeting and sign-off
Manufacture
CNC machining, assembly, and surface treatment
Validation & Delivery
CMM report, documentation pack, and training if required
Quality & Intellectual Property
Design Ownership: All fixture designs created under contract are the intellectual property of the customer upon completion and full payment. Prauna retains no rights to use, copy, or disclose customer designs. NDAs are signed as standard for all medical device projects.
Design Documentation: We supply a complete design history package including concept records, design review minutes, 3D models, manufacturing drawings, BOM, DFM report, and DFMEA. This package is formatted to support your ISO 13485 Design History File requirements.
Change Control: Post-delivery design changes are managed through a formal Engineering Change Request (ECR) process. All changes are documented, reviewed, and re-validated before implementation — maintaining the integrity of your production records.