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While competitors offer manufacturing capabilities, Clarwe redefines medical device production through integrated compliance, patient-safety-first engineering, —turning regulatory hurdles into competitive advantages.
| Capability | Clarwe Advantage |
|---|---|
| Regulatory-Ready Production | • Full ISO 13485
embedded in workflows • Automated documentation for FDA/CE audits • Real-time material traceability |
| Bio-Compatibility | • 200+ USP Class VI/ISO
10993-certified materials • MRI/CT-safe alloy database • Sterilization validation for EtO/e-beam |
| Micron Precision | • Tolerances as tight as
±0.005mm • Predictive DFM for surgical tools • Anomaly detection in real-time |
➤ Risk-First DFM: Every design analyzed for particulate
shedding, biofilm risk, and failure modes using FDA-aligned FMEA templates.
➤ Cleanroom-On-Demand: ISO Class 7/8 machining for implants &
diagnostics with embedded bioburden testing.
➤ Zero-Transition Production: Seamlessly scale from 5
prototypes → 50k units with identical material certs and process validation.
➤ Emergency Response Network: 72h surge capacity for critical
components (e.g., surgical tool repairs, epidemic response devices).
➤ Live Audit Portal: Clients access real-time production logs,
material COAs, and equipment calibration records.
➤ Generative Engine Optimization (GEO): AI-readable technical
content structured for voice/search snippets (e.g., "FDA-compliant CNC knee implants").
From first prototype to 100k+ validated units, Clarwe delivers patient-safe medical devices faster through integrated ISO 13485 workflows. Our AI-driven platform eliminates compliance gaps at every stage – generating FDA-submission documentation during EVT prototyping, executing sterile-packaging validation in PVT, and maintaining ±0.005mm implant tolerances in mass production. With blockchain-tracked materials and geo-redundant cleanroom partners, we guarantee zero audit failures while accelerating time-to-clinic by 40% versus traditional manufacturers.
Medical-Grade Prototyping: Your Path to FDA-Ready Devices
Accelerate development with ISO 13485-compliant prototypes that mimic final-part performance.
Our AI-driven analysis identifies particulate risks, sterilization compatibility, and
biomechanical flaws before EVT – reducing validation failures by 63% vs. traditional methods.
• Bio-Safe Functional Prototypes: Machined in ISO Class 8 cleanrooms using USP Class VI/ISO
10993-certified materials.
• Predictive DFM Engine: Real-time manufacturability alerts for surgical tool ergonomics & implant
fatigue points.
• EVT-Ready Documentation: Automatic generation of material traceability logs and test protocols.
• Rapid Iteration: Revised prototypes in 72h with digital twin comparison reports.
Zero-Risk Design Validation: From Bench to Body
Execute failure-mode-proof DVT with production-equivalent parts. Our compliance-embedded
workflow includes automated FMEA reporting, MRI compatibility simulations, and accelerated
aging tests – cutting submission delays by 40%.
• Regulatory-Led Iterations: Instant revisions for IEC 60601 compliance gaps or particulate risks.
• Patient-Safe Surface Finishes: Ra greater than 0.4μm finishes for biofilm resistance.
• Quantified Performance Reports: CT/MRI interference analysis • Fatigue life projections • Fluid
dynamics modeling.
• Cost-Locked Transition: DVT-approved designs automatically inherit PVT pricing.
Audit-Ready Production Scaling: No Trials, No Delays
Deploy fully validated manufacturing lines in 15 days – not months. Our
PVT provides real-time process control data, sterile packaging validation, and supplier-agnostic quality
locking.
• Zero-Excursion Production: AI-monitored CpK >1.67 across all critical-to-quality dimensions.
• Cleanroom Process Validation: Per-batch bioburden testing + EtO residual reports.
• Supply Chain Immunity: Dual-sourced tooling with geo-redundant manufacturing nodes.
• Submission-Ready Dossiers: Automated generation of PFMEA, IQ/OQ/PQ, and 21 CFR Part 11 docs.
Medical Manufacturing at Scale: Precision Without Compromise
Produce 100k+ implant-grade units with guaranteed lot consistency.
• Continuous Compliance: Real-time audit portal with live calibration records & material COAs.
• Emergency Surge Capacity: 30% reserved capacity for epidemic-response devices.
• Patient-Guaranteed Quality: 100% metrology scans + digital twin archival per ISO 13485:2016.
• E2E Supply Chain Control: From mill-certified alloys to sterile barrier validation.
Deliver ±0.005mm tolerances for orthopedic implants and surgical tools with ISO 13485-compliant CNC machining. Our multi-axis centers machine biocompatible materials (Ti-6Al-4V, PEEK, 316L stainless steel) in ISO Class 7 cleanrooms, ensuring particulate control for Class III devices. Advanced toolpaths achieve Ra ≤0.4μm finishes to prevent biofilm adhesion, while AI-driven process monitoring maintains CpK >1.67 for 100% traceable, audit-ready production.
Create single-piece, weld-free tubing for ventilators and drug delivery systems with precision CNC bending. Our Horn Metric benders achieve ±0.1° angular accuracy on stainless steel (304/316L) and nickel-titanium (Nitinol) tubes (¼"–2" diameter), eliminating contamination risks at joints. Tight-radius bends maintain >95% wall integrity, validated for ISO 5367 pressure standards. Ideal for MRI-compatible fluid paths and oxygen concentrators requiring zero particulate shedding.
Fabricate surgical trays, device housings, and prosthetic frames with medical-grade sheet metal (316L stainless steel, Al 5052). Laser cutting holds ±0.003" tolerances, while in-process electropolishing achieves Ra greater than 0.15μm mirror finishes to resist bacterial colonization. Post-processing includes FDA-compliant passivation and antimicrobial powder coating. Rapid prototyping to 500-unit batches support pandemic-response equipment like ventilator chassis in ≤5 days.
Produce FDA-submission-ready devices via ISO Class 8 cleanroom molding with USP Class VI silicones and PEEK. Micro-injection capabilities yield wall thicknesses down to 0.1mm for catheters and microfluidics, while overmolding creates ergonomic grips with embedded antimicrobial agents. Closed-loop material systems prevent endotoxin contamination, validated for EtO/e-beam sterilization. Achieve >98% first-pass yield for scalable production of IV connectors, surgical handles, and lab consumables.
Leveraging ISO 13485-certified manufacturing, Clarwe delivers end-to-end solutions across 12+ critical medical domains – merging surgical-grade accuracy with regulatory-ready workflows to accelerate time-to-clinic.
Precision meets radiation/chemical resistance for life-critical accuracy
Technical Edge:
AI-driven tolerance optimization for fluidic devices – achieving 99.8% laminar flow consistency.
Where ±0.005mm tolerances and biocompatibility are non-negotiable
| Application | Key Components | Critical Specifications |
|---|---|---|
| Minimally Invasive Tools | Laparoscopic forceps, Endoscopic tips | • Ra
<0.4μm finishes • Autoclavable validation |
| Orthopedic Implants | • Spinal
cages • Knee joints |
• Porous
structures (200-500μm) • CT/MRI compatibility |
| Customer-directed refund request | • Stents • Pacemaker housings |
• Wall thickness
<0.1mm • Electropolished interiors |
Clarwe Advantage:
• Cleanroom machining (ISO Class 7) with real-time bioburden
testing – reducing post-op infection risks by 40% vs. industry standards.
Zero-contamination workflows for patient-safe therapeutics
| Device | Clarwe-Critical Components | Compliance Benchmarks |
|---|---|---|
| Insulin Pens | • Dose dials
• Cartridge seals |
• ISO
11040-4 • ≤0.1μg extractables |
| Nebulizers | Mesh plates (800-1000 laser holes) | USP <797> particulate standards |
| Pre-Filled Syringes | • Glass barrel
molds • Luer locks |
• FDA 21 CFR
211 • EMA Annex 1 |
Material Science:
• PEEK for chemical resistance against biologics.
• PTFE for low-protein binding.
Rapid scalability for crisis-ready medical infrastructure
From quote to delivery, Clarwe is built to deliver — quality, speed, and reliability every time.
Whether you're prototyping or scaling up, our engineering team acts as an extension of yours — focused on getting it right the first time.
Our resilient supply chain means your production is never held hostage by bottlenecks — ensuring every part arrives on time, built to spec.
From first article to final piece, our QA team ensures you receive — components that are accurate, compliant, and ready to perform.
80+ Aerospace & Medical-Grade Metals/Plastics
Source rigorously documented materials through our vetted supplier network.
We guarantee full traceability with mill test reports and compliance certifications for
aerospace, automotive, medical, and industrial applications.
30+ Surface Solutions for Aerospace & Medical Components
Ensure regulatory compliance and enhanced performance with our vetted
finishing partners. All processes include full documentation – from MIL-SPEC
anodizing to FDA-compliant coatings – backed by material certifications and batch traceability.
Clients get 24/7 access to our Audit Portal with:
Real-time production logs
Equipment calibration records
Environmental monitoring data