verifiedDIN / ISO / ASTM Technical Compliance Matrix

Medical-Grade Manufacturing & Quality Assurance Standards

German steels, 5-axis robotic CNC, and multi-generation artisan hand-finishing under one documented quality system. Every tolerance on this page is a tolerance we measure, and every measurement is attached to the lot you receive.

±0.02 mm

Optical comparator tolerance

100%

Passivation tested lots

10,000

Cleanroom rating (ISO 7 class 10k)

ISO 13485

ISO certified management system

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LIVE METROLOGY STATION 04 · MITUTOYO OPTICAL SHADOWGRAPH 10x-50x Profile verification in real time Operator logged in · batch LOT-S25-74XN on the stage
Metrology Spotlight

Three numbers we hold ourselves to

Pivot friction torque0.12 - 0.18 N·m
Surface finish Ra0.15 µm polish / 0.40 µm satin
Core hardness uniformity±0.5 HRC across the section
info

Hardness is read from the finished instrument and logged against the heat code. If you need a specific band — 48 HRC for flexible forceps, 56 HRC for cutting edges — state it on the RFQ and we build to it.

Manufacturing Workflow

Six controlled stages, no hand-waving between them

Each stage releases to the next only when its own inspection gate is signed. Use the tabs to walk the process or scroll straight through.

Stage 01 of 06

Raw Metallurgy & Spectrometry

Optical emission spectrometry on every ingot batch before a bar enters the workshop. Chemistry is compared against ASTM F899 and EN 10204 3.1 limits, and the heat code is laser-marked onto the blank so traceability never breaks.

OES spectrometryEN 10204 3.1ASTM F899100% ingot batch
PROCESS 01 · SURGENTIS SIALKOTGATE 01
01
Raw Metallurgy & Spectrometry

Optical emission spectrometry on every ingot batch before a bar enters the workshop. Chemistry is compared against ASTM F899 and EN 10204 3.1 limits, and the heat code is laser-marked onto the blank so traceability never breaks.

OES spectrometryEN 10204 3.1ASTM F899100% ingot batch
02
Drop Forging & CNC Milling

350-ton closed-die forging establishes grain flow, then 14 five-axis centers and wire EDM finish box joints, ratchets, and micro-serrations within a ±0.005 mm tolerance window.

5-axis synchronous±0.005 mmWire EDM die-sink14 centers
03
Vacuum Heat Treatment

Inert argon atmosphere, controlled soak and double temper. Rockwell C-scale verification is taken from the finished part, not a witness coupon, so the reading describes the instrument you receive.

Inert argon48-56 HRCDouble temperPart-level test
04
Artisan Hand Craftsmanship

Box joints are lapped, pivot play checked under magnification, and spring tension hand-set by master technicians. Tips are hand-stoned to close the last micron without softening the edge.

Pivot < 0.015 mmArkansas 6000#Hand-set tension42 craftsmen
05
Ultrasonic & ASTM Passivation

Citric/nitric chemistry in a Class 10k ultrasonic cascade, finished with a micro-bead satin blast to Ra 0.35 µm that kills theatre-light glare without hiding surface defects.

ASTM A967Class 10kRa 0.35 µmCopper sulfate
06
Laser UDI & Cleanroom Pack

Fiber-laser DataMatrix, FDA UDI, CE mark, and your logo are annealed below the surface, then the instrument is sealed in a VCI barrier pouch inside an ISO 7 cleanroom.

GS1 / FDA UDISub-surface etchISO 7 cleanroomVCI barrier
Quality Control Matrix

Four gates that can stop a lot

Any non-conformance is quarantined, reworked, or scrapped — never downgraded and shipped quietly.

searchISO 7153-1

10x Optical Shadowgraph

Critical characteristics inspected on 100% of parts

GATE RESULT 100%
water_dropASTM A380 / ISO 16061

Boil & Copper Immersion

Zero rust, zero free-iron pickup over a 24 h cycle

GATE RESULT 0 pits
speedASTM E18 / ISO 6508

Rockwell C-Scale

Hardness band checked per grade on every heat

GATE RESULT 48-56 HRC
flareInternal SG-QP-11

Lateral Torque & Glare

Pivot torque and specular reflectance ceiling

GATE RESULT < 8.2%
Certifications Vault

Audit documents, downloadable without a sales call

Request any certificate as a countersigned PDF. We do not gate compliance paperwork behind a purchase order.

menu_bookFull document index
verified
ISO 13485:2016 TÜV SÜD·MD-10492-PAKFull medical-device manufacturing scope
Request this document
verified
CE MDR 2017/745 Emergo Europe·CE-EU-8921Class I / IIa, self-declared with notified-body review
Request this document
verified
US FDA 21 CFR 820 cGMP·FEI 3014902182Registered site with US agent in New York
Request this document
verified
ISO 9001:2015 Bureau Veritas·QA-PK-2024-09Industrial contract manufacturing scope
Request this document
Reproducible Recipes

What "to spec" actually means here

  1. Alloy first. State the grade (420B, 410, 440C, 316L, Ti-6Al-4V) and we lock the melt source.
  2. Hardness band second. Give a window, not a single number — we measure and report the actual distribution.
  3. Surface third. Mirror polish, satin blast, or electropolish changes glare and therefore clinical readability.
  4. Geometry last. Length, tip width, beak angle, and serration pitch are drawn from your master or ours.
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Send a drawing in STEP, DXF, DWG, or even a photograph with a scale reference. Our tooling engineers return a DFM report within 48 hours.

Quick tolerance referenceREV 3.2
CharacteristicAchievableStandard
Overall length±1.5 mmBS 5194-4
Tip / beak width±0.05 mmParallel gauge
Pivot lateral play< 0.015 mmISO 7153-1
Hardness spread±0.5 HRCASTM E18
Surface roughnessRa 0.15-0.40 µmISO 4287
Milled feature±0.005 mmWire EDM

Need the inspection dossier before you place an order?

Ask for a virtual cleanroom walkthrough, the metallurgy spec sheet, or the full signed inspection dossier for a reference lot you already buy from someone else.

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