๐ŸฅCMM-compatible datum design โ€” inspection without removing from fixture

Medical Manufacturing

Medical Fixtures

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4.9 (61 reviews)

Prauna medical fixtures are high-accuracy workholding solutions designed for machining, inspection, and assembly of medical device components. Engineered to maintain datum integrity across all operations โ€” from first-operation milling through final CMM inspection โ€” our fixtures eliminate re-fixturing errors and ensure that every part is held in a controlled, repeatable position throughout its manufacturing cycle.

Key Features

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Datum-referenced for through-process consistency
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CMM-compatible open design for in-fixture inspection
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Toggle, cam, and pneumatic clamping options
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316L SS, titanium, or hard-anodised aluminium
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Modular design for multi-product flexibility
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Full FAI with CMM report and material cert
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Compatible with 5-axis machining centres
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Custom pallet and tombstone configurations

Technical Specifications

Repeatability
ยฑ0.003 mm (standard); ยฑ0.001 mm (precision class)
Materials
316L SS, titanium Gr5, 7075-T6 aluminium (hard-anodised)
Clamping Force
Manual: 200โ€“2,000 N; Pneumatic: up to 5,000 N
Datum System
3-2-1 principle; compatible with DATUM-A/B/C GD&T scheme
Machine Interface
T-slot, Hirschmann zero-point, Erowa, 3R pallet options
Inspection Access
Open design allows CMM stylus access to all critical features
Documentation
CMM report, material cert (3.1), DFMEA support available
Lead Time
Prototype: 7โ€“12 working days; Production sets: 20โ€“30 days
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Product Description

Prauna medical fixtures are developed using datum flow analysis โ€” mapping the chain of datums from raw material through finished part to ensure dimensional closure at every stage. This prevents the accumulation of positional errors that occurs when different fixtures are used for different operations without a shared datum reference.

Our fixtures are designed with CMM access in mind from the outset. Clearance envelopes for the CMM stylus and probe rack are modelled in 3D during fixture design, ensuring that critical features can be measured while the part is clamped โ€” eliminating the set-up error introduced by removal and re-clamping for inspection.

For high-volume medical component production, we offer modular fixture systems that can be reconfigured for related product families. A common base with interchangeable locating inserts significantly reduces per-product tooling investment and lead time for new product introductions.

Industry Applications

๐Ÿ”ฉ CNC Machining

Milling and turning fixtures for implants, instrument housings, and fluid manifolds

๐Ÿ” CMM Inspection

Dedicated inspection fixtures for first article, SPC, and final inspection

๐Ÿ”ง Assembly Operations

Sub-assembly holding fixtures for bonding, welding, and fastening operations

๐ŸŽฏ Laser Processing

Precision holding fixtures for laser marking, cutting, and welding of medical parts

๐Ÿงช Testing & Validation

Fatigue test fixtures, burst test holders, and functional test rigs

๐Ÿญ Production Lines

Transfer fixture sets for automated assembly and inspection cells

Design & Manufacturing Process

1

Datum Analysis

Review of component GD&T and datum flow through all operations

2

Concept Modelling

3D fixture concept with clamping FEA for distortion analysis

3

Design Review

Customer approval of 3D model and DFM/risk assessment

4

Precision Machining

5-axis CNC and jig boring to sub-micron positional tolerances

5

CMM Verification

Full dimensional report on Zeiss CMM; datum repeatability test

6

FAI & Handover

First article inspection with customer part; documentation pack

Quality & Compliance

First Article Inspection: Every fixture is validated by machining and inspecting a sample of your actual component while fixtured. The resulting part CMM report is supplied as evidence of fixture performance, not just fixture geometry.

Repeatability Testing: Fixture repeatability is measured by loading and unloading the part 10 times and measuring the positional variation of the part datum features. Results are documented and supplied with the fixture.

ISO 13485 Support: We can supply fixture design documentation in a format compatible with your Design History File (DHF), including design input records, design output (3D model and drawings), and design verification (CMM report).

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