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Accelerating Medical Device Prototyping and Production

DEK has extensive experience manufacturing components for medical industry clients, offering on-demand production of diagnostic device enclosures, home-use medical devices, blood pressure monitor housings, and more at highly competitive prices. From early prototypes to final products, we possess comprehensive facilities and expertise to realize the most complex designs, compliant with ISO 13485 standards.
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Prototipos de dispositivos médicos
Introduction

Custom Precision Machining for Medical Device Prototypes

Custom Precision Machining for Medical Device Prototypes

Medical prototypes often involve micro-scale geometries, tight fits, sharp internal corners, and strict biocompatibility. Polished surfaces and burr-free edges are essential to pass clinical validations.

DEK applies 5-axis CNC, micro-milling, and EDM to handle complex contours and narrow slots. Our ISO 13485-aligned workflows and FDA-compliant materials ensure biocompatibility and traceable process control.

All parts are inspected using CMM, vision measurement systems, and laser micrometers to ensure every feature meets design intent before clinical testing.

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±0.01mm Tolerance

Achievable on critical fits

Ra 0.2μm Surface Finish

Polished or EDM textures available

Wall Thickness Down to 0.3mm

Consistent on medical-grade plastics and metals

Prototype in 4–7 days

Including polishing and validation reports
capabilities

Capacidad de mecanizado

Micro-Machining for Tight Features

Medical prototypes often require channels or details <1mm. We apply micro-end mills (0.2–0.5mm), reduced tool chatter, and controlled spindle RPM to maintain dimensional accuracy within ±0.01mm.

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5-Axis Machining for Complex Geometry

Prototypes like orthopedic implants often require compound curves and undercuts. We use simultaneous 5-axis setups to reduce repositioning error and achieve accurate multi-face geometry in a single clamping.

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Mirror Polishing & Surface Control

For contact surfaces, Ra 0.2μm is achieved through mechanical polishing and passivation. This improves biocompatibility and visual inspection. Internal burrs are removed via ultrasonic cleaning.

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Certified Plastic Machining

Materials like PEEK, Ultem, or medical-grade Nylon require sharp tools and thermal control. We pre-dry, use high rake angles, and ensure no burning or warping on thin-walled parts.

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Threaded Micro-Holes & Inserts

We can machine M1–M3 threads with precision taps and inspect with go/no-go gauges. Insert installation is also supported with force validation and retention tests.

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Certified Quality Systems in Place

All workflows are based on ISO 13485 and ISO 9001. We provide FAI, full inspection reports, and traceable material certs for every lot.
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Controlled Surface & Clean Packaging

Parts are ultrasonic cleaned and sealed in dust-free packaging. Surface inspected under magnification to meet Ra and visual specs
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Professional DFM Feedback

Before machining, all drawings are reviewed by senior programmers with medical machining experience to avoid design traps.
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Tight Project Tracking

We manage prototyping via ERP and dedicated project leads. Clients receive updates at each stage – machining, inspection, and shipment.
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Low Volume to Scale-Up

From 1-piece validation to low-volume builds (<500 pcs), our tooling and inspection adapt quickly, saving NPI cost and time.
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TESTIMONIALS

Testimonios

Lo que nos diferencia

DEK provides the precision, speed, and zero-defect manufacturing that mechanical engineers trust for their most critical applications.

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6-12 H

6–12 Hour Quotes

You get accurate quotes within half a day—evaluated by real engineers, not automated tools.
1-Piece

1-Piece Minimum

We support 1-off validation parts, ideal for design iterations and fast regulatory submission.
4-7 Day

4–7 Day Delivery

Typical prototype lead time, including polishing and full QC—ready for testing or assembly.
PREGUNTAS FRECUENTES

Prototipo de dispositivo médico Preguntas frecuentes

We review the 3D file, tolerances, and material to define the correct process—usually within 6–12 hours.
Yes. For Ø<5mm holes or slots, we apply CMM or pin gauge inspection to validate tolerance.
All parts come with material certs. We can also provide RoHS, REACH, and lot traceability upon request.
4–7 working days for medical parts with polishing and full inspection. Confirm case-by-case.
Yes. We use micro end mills and EDM for <0.3mm features, with burr control and optical inspection.
Yes, from 1 to 500 pcs. We adjust tooling and inspection plans to fit your stage.
We operate under ISO 13485-aligned workflows. Certificates and process audits available.
Post-machining, all parts are deburred under magnification. We can also apply passivation if needed.
Yes. We sign NDAs and store files securely with restricted access. Only your team and our engineers can view them.
Yes. CMM, height gauge, and optical comparator reports are included, depending on feature type.

Put Your Medical Device Prototype into Production Today

Send us your drawings—we’ll provide fast DFM feedback and a precise quote, no minimum order.

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DEK
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