๐Ÿฅ ISO 13485-compatible design and documentation available on request

Medical Manufacturing

Medical Jigs

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5.0 (44 reviews)

Prauna medical jigs are precision-machined positioning and assembly tools engineered for the demands of medical device manufacturing. Designed to ensure accuracy, repeatability, and reliability across production runs, our jigs enable consistent part orientation, hole drilling, bonding, and sub-assembly operations on medical components including implants, surgical instruments, catheters, and sensor housings.

Key Features

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Positional accuracy to ยฑ0.005 mm
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316L stainless steel & hard-anodised aluminium
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V-locators, dowel pins & precision bushings
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Autoclave-compatible sterilisable designs
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Quick-change insert system for product families
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Custom designed from customer drawings or samples
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Prototype through production quantities
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Inspection report & material certification supplied

Technical Specifications

Positional Accuracy
ยฑ0.005 mm (standard); ยฑ0.002 mm (precision class)
Materials
316L SS, 17-4PH SS, 6061-T6 / 7075-T6 aluminium, titanium Grade 5
Surface Finish
Ra 0.8 ยตm (standard); Ra 0.4 ยตm (polished); electropolished on request
Locating Elements
Diamond pins, round pins, V-blocks, precision bushings (H7/h6)
Clamping
Toggle clamps, cam locks, screw clamps, pneumatic (custom)
Documentation
Dimensional inspection report, material cert (EN 10204 3.1), traceability
Sterilisation
Autoclave-compatible (SS variants); EtO compatible (all materials)
Lead Time
Prototype: 5โ€“10 working days; Production: 15โ€“25 working days
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Product Description

Prauna medical jigs are developed through a rigorous design-for-manufacture process that begins with understanding your process requirements โ€” part geometry, dimensional tolerances, operator ergonomics, and cleanroom compatibility. Our engineering team uses SolidWorks and CATIA to model jig assemblies in full 3D prior to machining, allowing design reviews and interference checks before any material is cut.

Locating elements are selected to the 3-2-1 principle to constrain all six degrees of freedom without over-constraining the part. Precision ground dowel pins (h6 tolerance), diamond-form locating pins, and V-blocks are used for datum references. All locating surfaces are hardened and ground to Ra 0.8 ยตm or better to ensure repeatability across thousands of production cycles.

Every jig is validated with a dimensional inspection report generated on our CMM (Zeiss Contura) and supplied with the first article. For medical device manufacturers requiring ISO 13485 traceability, we supply full material certification, heat numbers, and dimensional records formatted to your quality management requirements.

Industry Applications

๐Ÿฆด Orthopaedic Implants

Drilling and reaming jigs for bone plates, screws, and hip/knee implant components

๐Ÿ”ฌ Surgical Instruments

Assembly jigs for laparoscopic tools, forceps, retractors, and cutting instruments

๐Ÿ’‰ Catheter & Tube Assembly

Bonding and tipping jigs for catheter shafts, balloon catheters, and guidewires

๐Ÿซ€ Cardiovascular Devices

Stent crimping jigs, valve ring assembly fixtures, and wire forming guides

๐Ÿงฌ Diagnostic Equipment

Sensor alignment jigs for PCR instruments, flow cells, and microfluidic devices

๐Ÿ‘๏ธ Ophthalmic Devices

Lens alignment jigs for IOL assembly and ophthalmic instrument sub-assemblies

Our Design & Manufacturing Process

1

Requirements Review

We review your part drawings, process flow, and tolerance requirements

2

Concept Design

3D CAD concept with locating scheme and clamping strategy

3

Design Approval

Customer review of 3D model and DFM report before machining

4

CNC Machining

5-axis CNC milling and turning to ยฑ0.005 mm tolerance

5

CMM Inspection

Full dimensional inspection on Zeiss CMM with report

6

Delivery & Validation

Delivered with inspection report, material cert, and usage guide

Quality & Compliance

Material Traceability: All raw materials are sourced from certified suppliers with EN 10204 3.1 mill certificates. Heat numbers are recorded against each finished jig for full traceability back to raw material origin.

Dimensional Inspection: Each jig is inspected on a Zeiss Contura CMM using a calibrated probe. Inspection reports cover all critical dimensions, GD&T callouts, and surface finish measurements. Reports are issued in PDF and can be supplied in your company's format.

ISO 13485 Compatibility: Our manufacturing documentation and traceability records are structured to support your ISO 13485 quality management system. We can supply design history documentation, risk assessment input (DFMEA), and validation support data upon request.

Cleanroom Compatibility: Stainless steel jigs can be passivated, electropolished, and packaged for cleanroom environments (Class 7 / ISO 4). Aluminium jigs are hard-anodised and bead-blasted to prevent particle generation.

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