Medical Device
ISO 13485 Compliant
Medical Device
& High-Cleanliness
Precision Parts
12 precision machined product lines for surgical instruments, minimally invasive devices, endoscopes, orthopaedic tools, diagnostic equipment, and implant-adjacent hardware — where material purity, surface finish, dimensional accuracy, and complete traceability are non-negotiable.
ISO 13485:2016 Quality System
ASTM F136 Ti-6Al-4V ELI
ASTM F138 SS316L Implant Grade
FDA 21 CFR 820 Process Control
Ra ≤0.4
µm Surface
Ti ELI
ASTM F136
12
Product Lines
ISO 13485
Quality System
Ra ≤0.4µm
Surface Finish
±0.005mm
Precision Tolerance
24hr
Quote Turnaround
Surgical Instrument Structures ✦
Medical Device Housings ✦
Medical Clamp Parts ✦
Minimally Invasive Connectors ✦
Precision Instrument Handles ✦
Endoscope Structural Parts ✦
High-Precision Guide Parts ✦
Orthopaedic Instrument Parts ✦
Diagnostic Equipment Parts ✦
High-Cleanliness Connectors ✦
Titanium Alloy Medical Components ✦
High-Corrosion-Resistance Brackets ✦
Surgical Instrument Structures ✦
Medical Device Housings ✦
Medical Clamp Parts ✦
Minimally Invasive Connectors ✦
Precision Instrument Handles ✦
Endoscope Structural Parts ✦
High-Precision Guide Parts ✦
Orthopaedic Instrument Parts ✦
Diagnostic Equipment Parts ✦
High-Cleanliness Connectors ✦
Titanium Alloy Medical Components ✦
High-Corrosion-Resistance Brackets ✦
📋
ISO 13485:2016
Medical Device QMS
Quality management system aligned to ISO 13485 — design control, process validation, traceability, and CAPA maintained throughout production.
🔬
ASTM F136 / F138
Implant-Grade Materials
Ti-6Al-4V ELI per ASTM F136 and SS316L per ASTM F138. Mill certification and heat number traceability on every material lot.
🧪
ISO 10993
Biocompatibility
Material selection and surface treatment decisions referenced against ISO 10993. Documentation available for device manufacturer’s biological evaluation.
🏭
FDA 21 CFR 820
Process & Traceability
Process traveller, material certificate, dimensional inspection report, and surface treatment certificate maintained for every part.
Full Product Range
12 Medical Device & High-Cleanliness
Precision Product Lines
4 product categories · All parts to drawing · ISO 13485 documentation · Clean-room packaging
Surgical & Minimally Invasive Instruments
Body frames, pivot housings, ratchet mechanisms, and structural members for surgical scissors, forceps, clamps, and MIS tools. SS316L or Ti-6Al-4V ELI with full material traceability. All internal corners ≥R0.5 mm. Ra ≤0.4 µm on all product-contact surfaces.
MDP-001
SURGICAL INSTRUMENTS / 001 — FEATURED
Surgical Instrument Structural Parts
Body frames, pivot housings, ratchet mechanisms, and structural members for surgical scissors, forceps, clamps, needle holders, and retractors. SS316L or Ti-6Al-4V ELI with full material traceability. Internal corners ≥R0.5 mm. Ra ≤0.4 µm on product-contact surfaces. Passivation per ASTM A967. Zero detachable fragments — all features machined from solid.
SS316L · Ti-6Al-4V ELI · SS17-4PHGet Quote
MDP-002
SURGICAL INSTRUMENTS / 002
Medical Device Housings
Outer enclosures for handheld surgical and diagnostic devices — probe bodies, handle housings, and control grip bodies. Ergonomic geometry from solid billet. All edges chamfered or radiused for safe handling.
SS316L · Al6061 · Ti · PEEKGet Quote
MDP-003
SURGICAL INSTRUMENTS / 003
Medical Clamp Parts
Jaw inserts, spring-loaded clamp bodies, ratchet pawl assemblies, and locking ring mechanisms for surgical clamps. Pivot pin fit H7; ratchet tooth profile precision-milled to consistent engagement force.
SS316L · SS17-4PH · Ti-ELIGet Quote
MDP-004
SURGICAL INSTRUMENTS / 004
Minimally Invasive Connectors
Trocar and laparoscopic instrument connectors, shaft-to-handle adapters, and articulation joints. Thin-wall shaft from Ø3 mm. SS316L with full EP surface finish. Articulation range confirmed by CMM.
SS316L EP · Ti-ELI · PEEKGet Quote
Materials: SS316L · Ti-6Al-4V ELI · SS17-4PH · PEEK
Request All 4 →
Endoscopes, Handles & Guide Parts
Insertion tube body connectors, light guide socket housings, bending section frames, ergonomic instrument handles, and wire guide cannulae. OD ±0.01 mm; all SS316L surfaces electropolished for autoclave compatibility.
MDP-005
ENDOSCOPES & HANDLES / 005 — FEATURED
Endoscope Structural Parts
Insertion tube body connectors, light guide socket housings, bending section frames, and distal tip structural components. OD ±0.01 mm for insertion tube fit. Internal light guide channel Ra ≤0.4 µm. All SS316L surfaces electropolished. Autoclave compatible — no trapped air cavities. Process traveller and dimensional report per piece.
SS316L EP · Ti-6Al-4V · PEEKGet Quote
MDP-006
ENDOSCOPES & HANDLES / 006
Precision Instrument Handles
Ergonomic handle bodies with knurled grip to DIN 82. Internal passage for cable or optical fibre. Mass verified after machining.
SS316L · Al6061 · Ti · PEEKGet Quote
MDP-007
ENDOSCOPES & HANDLES / 007
High-Precision Guide Parts
Wire guide cannulae, introducer channel liners, and precision bore guide bodies. Bore H6; roundness ≤0.003 mm. Ra ≤0.2 µm for low-friction catheter tracking.
SS316L · Ti · PEEK · PTFE LinedGet Quote
Materials: SS316L EP · Ti-6Al-4V · PEEK · PTFE Lined
Request All 3 →
Orthopaedic Instruments & Diagnostic Equipment
Cutting block inserts, trial implant alignment jigs, drill guide sleeves, diagnostic device structural parts, and fluid-path connectors. Guide slots H7; Ti colour anodize for size-set identification; CMM per size and per side.
MDP-008
ORTHOPAEDIC & DIAGNOSTIC / 008 — FEATURED
Orthopaedic Instrument Components
Cutting block inserts, trial implant alignment jigs, reaming guide bodies, drill guide sleeves, and broach handles. Guide slots H7; guide sleeve concentricity ≤0.005 mm. Ti anodized to colour-coding scheme. Full size-set (L/R, Size 1–7) with CMM per size and per side.
Ti-6Al-4V · SS316L · SS17-4PHGet Quote
MDP-009
ORTHOPAEDIC & DIAGNOSTIC / 009
Medical Diagnostic Equipment Parts
Structural parts for IVD devices, analysers, and imaging equipment. Sample handling arms, optical sensor mounts, and flow cell bodies. Non-contaminating materials; clean-room packaged.
SS316L · Al6061 · PEEK · AcetalGet Quote
MDP-010
ORTHOPAEDIC & DIAGNOSTIC / 010
High-Cleanliness Connectors
Fluid path connectors, luer-lock adapters, and tubing interface fittings. Wetted surfaces EP Ra ≤0.4 µm. Helium leak tested. No retained chips per flushing protocol.
SS316L EP · Ti · PEEKGet Quote
Materials: Ti-6Al-4V · SS316L · SS17-4PH · PEEK · Acetal
Request All 3 →
Titanium, Corrosion-Resistant & Structural Medical Parts
Ti-6Al-4V ELI (ASTM F136) components for surgical instruments and implant-adjacent hardware; SS316L and Hastelloy C276 structural brackets for equipment in aggressive chemical or sterilisation environments.
MDP-011
TITANIUM & CORROSION-RESISTANT / 011 — FEATURED
Titanium Alloy Medical Components
Ti-6Al-4V ELI (ASTM F136) for surgical instruments, orthopaedic tool bodies, and implant-adjacent hardware. ELI grade: enhanced ductility and fracture toughness for cyclic-load instruments. Type II anodize for size colour-coding. Ra ≤0.4 µm. Full mill certificate, heat number, and chemical composition cert with every delivery.
Ti-6Al-4V ELI (ASTM F136) · Grade 2 TiGet Quote
MDP-012
TITANIUM & CORROSION-RESISTANT / 012
High-Corrosion-Resistance Brackets
Structural brackets, cable management clips, and mounting frames for high-humidity and frequent-sterilisation environments. SS316L passivated per ASTM A967. Hastelloy C276 for highest chemical resistance.
SS316L · Hastelloy C276 · Ti Gr2Get Quote
Materials: Ti-6Al-4V ELI · Grade 2 Ti · SS316L · Hastelloy C276
Request All 2 →
Manufacturing Capability
What Medical Precision Parts Demand from a Machining Partner
Ra ≤0.4
µm Surface
ISO 13485
Quality System
100%
Traceability
Clean-Room
Packaging
📋
Full Material Traceability — Mill Cert to Finished Part
Every medical part links its raw material mill certificate through the machining process traveller to the finished part inspection record. Chain of custody from raw material to shipment — required for ISO 13485 and FDA 21 CFR 820 compliance.
Mill certHeat numberProcess travellerInspection record
✦
Surface Finish Ra ≤0.4 µm — Measured & Certified
All product-contact surfaces machined and measured by contact profilometer. Ra, Rz, and Rmax values recorded per specified location. Not assumed from cutting parameters — physically measured and documented. EP surfaces achieve Ra ≤0.25 µm in SS316L.
Ra / Rz / RmaxProfilometer certEP Ra ≤0.25µm
🔬
Autoclave & Sterilisation Compatibility Design
Every instrument part reviewed for autoclave steam sterilisation (134°C, 3 bar) compatibility at DFM stage. Blind holes counter-bored to prevent steam trapping. Internal radii ≥R0.5 mm. Bi-metallic combinations reviewed for galvanic corrosion risk. All confirmed in DFM report before machining begins.
No blind holesR0.5mm min radiusGalvanic review
🏭
Implant-Grade Material — ELI Grade Stocked
Ti-6Al-4V ELI (ASTM F136) stocked as standard — not ordered on demand. ELI grade has tighter limits on oxygen, nitrogen, hydrogen, and iron than standard Ti-6Al-4V — providing improved ductility and fracture toughness for cyclic load applications.
ASTM F136 ELIASTM F138 SS316LIn stock
🏫
Clean-Room Packaging & Sterilisation-Ready Delivery
All medical parts cleaned with ultrasonic DI water wash and IPA rinse. Double-bagged in medical-grade packaging film, heat-sealed. Delivered sterilisation-ready — customer can send directly to EtO, gamma, or autoclave without re-cleaning.
DI water / IPA rinseMedical packagingSterile-ready
Precision Specifications
Tolerances & Standards — Medical Precision Parts
📐
Achievable Tolerances by Feature
General Bore / OD
±0.005 mm
Guide Bore H6
H6 tolerance
Bore Roundness
≤0.003 mm
Endoscope OD
±0.01 mm
Instrument Handle
±0.02 mm
Surface Ra (contact)
≤0.4 µm
EP Surface Ra
≤0.25 µm
Min Shaft Dia
Ø3 mm
🔬
Quality & Compliance Specifications
Quality System
ISO 13485
Medical device QMS. Process traveller and CAPA for all medical orders.
Ti Material Standard
ASTM F136
Ti-6Al-4V ELI in stock. Chemical composition cert with every lot.
SS Material Standard
ASTM F138
SS316L implant-grade stainless. Passivation per ASTM A967.
Passivation Standard
ASTM A967
Citric acid passivation. Report included with SS orders.
Sterilisation Compat.
134°C / 3 bar
Autoclave steam. EtO and gamma available in SS & Ti.
Leak Test (fluid path)
10−6 mbar·l/s
Helium leak test on fluid-path connectors. Cert included.
Surface Treatments
Medical-Grade Surface Treatments for Device Compliance
All treatments selected for sterilisation compatibility, biocompatibility, and corrosion resistance.
✦
Electropolishing (EP)
SS316L to Ra ≤0.25 µm. Removes embedded iron and micro-roughness. Creates Cr-rich passive layer resistant to corrosion and bio-film formation. Required for all fluid-wetted medical surfaces.
SS316LFluid PathEndoscopes
🛡
Passivation (ASTM A967)
Citric acid passivation removes free iron from SS surfaces, forming a stable Cr₂O₃ passive layer. Required for all SS medical instrument surfaces. Report per ASTM A967 included.
All SS gradesInstruments
🎨
Titanium Colour Anodize
Type II anodize on Ti-6Al-4V ELI for size colour-coding. Voltage-controlled colour. Integral oxide layer — no coating delamination risk in autoclave.
Ti-6Al-4V ELISize Coding
💎
Precision Polishing
Hand polishing to mirror finish Ra ≤0.1 µm for premium surgical instruments and endoscope components requiring optical-quality appearance.
Premium InstrumentsEndoscopes
⬜
Sandblasting / Bead Blast
Glass bead blasting to Ra 0.8–1.6 µm for matte, non-reflective finish. Reduces surgical field glare. Followed by passivation for SS parts.
SS InstrumentsNon-Reflective
⚗
Nitride / DLC Coating
TiN or Diamond-Like Carbon coating on cutting edges for extended service life. Hardness 2,000–4,000 HV. Biocompatible. Used on orthopaedic reamers and drill guides.
Cutting ToolsReamers
🧪
Laser Marking (Device ID)
Laser engraved part number, lot number, size, side (L/R), and UDI per EU MDR 2017/745 and FDA UDI Final Rule. Permanent, corrosion-resistant on all metals.
UDI / MDRAll Metals
Material Selection
Medical-Grade Materials for Clinical Applications
Ti-6Al-4V ELI
The definitive material for surgical instruments and orthopaedic device components. ELI (Extra Low Interstitial) grade has tighter limits on O₂, N₂, H₂, and Fe than standard Ti-6Al-4V — providing improved ductility and fracture toughness under cyclic load. Colour anodize compatible. Biocompatible per ISO 10993. ASTM F136 certified stock.
Standard
ASTM F136 ELI
Tensile Strength
860 MPa
Density
4.43 g/cm³
Biocompatibility
ISO 10993 compatible
Surface Treatment
Type II Anodize · Passivation
ASTM F136 ELIISO 10993Colour Anodize
Surgical InstrumentsOrthopaedic ToolsInstrument HandlesImplant-Adjacent Parts
SS316L — ASTM F138
Implant-grade austenitic stainless steel. Low carbon (L grade) prevents carbide precipitation. Excellent corrosion resistance in chloride environments. Electropolishable to Ra ≤0.25 µm. Passivated per ASTM A967.
Standard
ASTM F138 / ISO 5832-1
Tensile Strength
490 MPa min.
Corrosion
Excellent — saline and body fluid resistant
Surface
EP Ra ≤0.25 µm · Passivation ASTM A967
ASTM F138ElectropolishableAutoclave Stable
Surgical ClampsEndoscope BodiesFluid ConnectorsMIS Instrument Bodies
Stainless SS17-4PH
Precipitation-hardened stainless combining high strength (~1,100 MPa in H900) with good corrosion resistance. Used for high-stress instrument components where SS316L lacks sufficient strength.
Tensile (H900)
1,100 MPa
Hardness
HRC 38–44 (H900)
Best Use
High-load instrument pivot bodies and springs
1,100 MPaH900 Condition
High-Load PivotsClamp Ratchet BodiesSpring Mechanisms
Hastelloy C276
Nickel-molybdenum-chromium superalloy with exceptional resistance to pitting, crevice corrosion, and stress corrosion cracking. Used for components in contact with disinfecting agents, oxidising acids, and bleach solutions.
Tensile Strength
790 MPa
Corrosion
Excellent in bleach, HCl, and oxidisers
Best Use
Components exposed to harsh disinfectants or oxidising sterilants
Pitting ResistantChemical Resistant
Disinfectant-Exposed PartsChemical-Contact BracketsHigh-Corrosion Environments
Production Workflow
From Drawing to ISO 13485 Documented Delivery
01
DFM Review — Medical Compliance Check
Drawing reviewed for blind holes, internal radii, autoclave compatibility, and material selection. ISO 13485 compliance checklist completed. Feedback within 24 hours including DFM report.
02
Material Receipt & Traceability Setup
ASTM F136 Ti-ELI or ASTM F138 SS316L raw material received with mill certificate. Heat number and material grade recorded to process traveller before first cut.
03
CNC Precision Machining
All critical dimensions machined to drawing tolerance. Internal corners ≥R0.5 mm. Blind holes counter-bored. In-process gauging on bore diameters and surface finish spot-check during production.
04
Surface Treatment
Passivation (ASTM A967) for SS; electropolish to Ra ≤0.25 µm for fluid-path surfaces; Type II anodize for Ti colour coding; laser marking for UDI/lot number. Profilometry measured and recorded.
05
CMM Dimensional Inspection
Full CMM dimensional report per drawing GD&T callouts. First Article Inspection (FAI) on every new part number. Results recorded to part serial/lot number.
06
Clean-Room Cleaning & Packaging
Ultrasonic DI water wash, IPA rinse, and nitrogen dry. Medical packaging film, heat-sealed, double-bagged. Full documentation pack enclosed. Sterilisation-ready.
Quality System
Every Medical Part Documented, Tested & Certified
📋
Process Traveller — Every Part, Every Step
Material receipt, machining, surface treatment, and inspection each recorded on a process traveller linked to the part serial or lot number. Complete manufacturing history retrievable at any time.
🔬
First Article Inspection on Every New Part Number
Full CMM dimensional report, surface roughness profilometry, material certificate verification, and surface treatment certificate — completed before production approval. FAI report archived for device manufacturer’s Design History File.
✦
Surface Roughness Measured — Not Assumed
Ra value physically measured by contact profilometer at specified locations. Not estimated from cutting parameters. Measurement results in delivery documentation.
🔗
Material Traceability — Heat Number to Shipment
Raw material mill certificate, heat number, and chemical composition trace through to finished part CMM report. Complete chain of custody for regulatory submission and device recall readiness.
📋
ISO 13485:2016
Medical device quality management system
🔬
ASTM F136
Ti-6Al-4V ELI implant-grade material
🧪
ASTM F138
SS316L implant-grade stainless
🛡
ASTM A967
Passivation certification for stainless
💉
ISO 10993
Biocompatibility framework reference
📐
CMM FAI Report
First article inspection on every new P/N
Our Advantage
Why Medical Device Teams Specify Our Parts
F136
ASTM F136 ELI — Stocked, Not Special-Order
Ti-6Al-4V ELI (ASTM F136) stocked as standard. Chemical composition certificate with every lot. ELI grade’s tighter interstitial limits matter for cyclic-load surgical instruments.
Ra
Surface Finish Measured, Not Assumed
Ra measured by contact profilometer after machining and after surface treatment — both values documented. Not estimated from cutting parameters. In your delivery package, not available on request.
DHF
Documentation Ready for Your Device File
Process traveller, material mill cert, FAI CMM report, surface treatment cert, and profilometry cert — all in one delivery package, structured to support your Design History File and Device Master Record.
DFM
Medical DFM — Bio-Burden, Autoclave, Traceability
Every medical part reviewed against a medical DFM checklist. Blind holes, internal radii, autoclave compatibility, sterilisation trap risks, and material-galvanic combinations reviewed before first cut.
Get a Quote
Send Your Drawing.
Get a Quote.
Every enquiry includes a DFM review — tolerance feasibility, material confirmation, and process approach confirmed before production starts. MOQ 1 piece.
24hr
Quote Response
MOQ 1
Prototypes OK
ISO
9001:2015
📐
DFM Review on Every Enquiry
Tolerance feasibility, fixturing strategy, and material confirmation. Specific, actionable feedback — not generic pushback.
🎯
First Article Inspection — Standard
FAI report on every new run. Material certs and surface treatment certs included with every shipment.
🔄
Same Process: Prototype to Production
Process plan from your prototype applies to production batches. No re-qualification when you scale.
⚙
3 / 4 / 5-Axis CNC + Turning
Complex structural parts, shafts, housings, and transmission components. Metals and engineering plastics.
ISO 9001:2015
3/4/5-Axis Milling
CNC Turning
CMM Inspection
Global Delivery