What manufacturing processes do you offer for medical devices?

Yes. We support CNC machining, 3D printing, sheet metal fabrication, metal casting, injection molding, silicone molding, and vacuum casting, plus finishing, assembly, and inspection. The right process depends on geometry, material, quantity, validation goals, and production requirements.

Are your manufacturing facilities certified for medical device production?

Yes. Mastars maintains ISO 13485:2016 and ISO 9001:2015 quality management system certifications. Inspection plans, material documentation, FAI/CMM records, and traceability requirements can be defined by project. Certification does not make every material or component automatically approved for clinical or patient-contact use.

What medical-grade materials can you machine or mold?

It depends on the application. We work with stainless steel, titanium, aluminum, PEEK, polycarbonate, nylon, POM, silicone, and other engineering materials. For patient-contact, sterilizable, or regulated components, specify the exact material grade, sterilization method, and required certificates. “Medical-grade” should be confirmed at the material and project level.

What tolerances can you achieve for medical components?

For suitable CNC features, Mastars can achieve tolerances down to ±0.005 mm. Tighter or highly critical requirements should be reviewed feature by feature because material, geometry, wall thickness, workholding, finishing, and inspection method all affect achievable tolerance. Critical dimensions can be verified with CMM and first article inspection when required.

Can you support medical device development from prototype to production?

Yes. We support concept prototypes, EVT, DVT, PVT, pilot builds, and repeat production. A prototype that passes fit or functional testing is not automatically production-ready; tooling, process window, shrinkage, inspection criteria, material documentation, and revision control still need to be confirmed before scale-up.

What is your typical lead time for medical prototypes and production parts?

Often as fast as 3 days for suitable prototype parts. Tooling, molded validation builds, and production lead times depend on geometry, material, finish, inspection or documentation requirements, and quantity. We confirm the schedule after reviewing the files rather than applying one standard lead time to every medical project.

How do you protect the intellectual property (IP) of our medical device designs?

Yes. We can work under NDA and restrict project information to the teams involved in quoting, engineering, manufacturing, and quality. If your project has additional file-handling or access-control requirements, include them with the RFQ so they can be agreed before data transfer.

Medical Parts One-Stop Manufacturing Services

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Manufacturing Solutions for Medical Devices

CNC Machining

Precision metal and plastic parts for critical features, fixtures, and functional medical components.

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3D Printing

Fast prototypes and complex geometries for models, fixtures, and design validation.

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Injection Molding

Repeatable plastic and silicone components for validation builds and ongoing production.

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Sheet Metal Fabrication

Metal housings, panels, brackets, and equipment structures for medical devices and systems.

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Metal Casting

Cast metal housings, brackets, and structural components for repeat production.

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Vacuum Casting

Low-volume polyurethane parts for fit, appearance, and functional validation.

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From Medical Device Prototyping to Production

Each stage reduces a different risk—from fit and function to process stability and repeat production.

Prototype

EVT

DVT

PVT

Production

Prototype Component Development

Accelerate early medical device development with prototypes for design evaluation, fit testing, and functional verification.

Proof-of-Concept Models: Validate overall form, product envelope, ergonomics, and basic interfaces.

Functional Prototypes: Test fit, assembly, motion, sealing, load paths, and key functions.

Appearance Models: Review visible surfaces, CMF, user-facing details, and design intent.

Design Iterations: Apply test results before locking critical geometry or investing in tooling.

Engineering Validation Test

Verify engineering designs through functional prototypes before committing to production tooling.

Mechanical Verification: Evaluate strength, stiffness, movement, sealing, and functional loads.

Assembly Validation: Check mating interfaces, tolerance stack-up, fasteners, snaps, connectors, and moving features.

Material Evaluation: Use production-intent materials where performance depends on material behavior.

Engineering Optimization: Resolve wall thickness, tool access, draft, undercuts, support, and critical-dimension risks.

Design Validation Test

Validate product design maturity using production-representative parts and processes.

Design Verification: Build parts against controlled drawings, revisions, and defined acceptance criteria.

Tolerance Validation: Measure critical dimensions and GD&T and confirm assembly fit across mating components.

Surface & Appearance Review: Confirm finishes, visible surfaces, markings, and dimensional impact from secondary operations.

Design Improvement: Close remaining design risks before pilot manufacturing.

Production Validation Test

Prepare medical devices for manufacturing through pilot builds and process validation.

Pilot Production: Run initial builds using the intended tooling, materials, process settings, and inspection plan.

Process Validation: Verify process stability, repeatability, work instructions, and key manufacturing parameters.

Quality Verification: Confirm critical dimensions and acceptance requirements using FAI, CMM, or other specified inspection methods.

Production Preparation: Lock revisions, inspection criteria, documentation, packaging, and production release requirements.

Medical Device Production

Transition validated designs into repeat production with controlled processes, inspection, and revision control.

Production Manufacturing: Support flexible production from 1 to 100,000+ units as program demand changes.

Quality Control: Control critical dimensions, appearance, assembly, and functional requirements across production lots.

Supply Support: Coordinate materials, tooling maintenance, production scheduling, assembly, and delivery.

Continuous Improvement: Use production data and issue feedback to improve process stability, cost, and repeatability.

Custom Medical Device Manufacturing Solutions

Medical devices often combine parts with different materials, tolerances, finishes, cleanliness requirements, and production volumes. Mastars coordinates CNC machining, 3D printing, sheet metal, metal casting, tooling, injection molding, silicone molding, finishing, assembly, and inspection around the same design revision and acceptance criteria.

For patient-contact, sterilizable, or otherwise regulated components, material grade, required documentation, and process qualification should be defined at the start of the project.

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Other Industries We Serve

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Consumer Electronics

Automotive

Industrial Equipments

Medical Components We Manufacture

Component Categories	Typical Medical Components
Diagnostic & Monitoring Components	Diagnostic Equipment Housings, Portable Testing Device Enclosures, Sensor Mounts, Monitoring System Components, Laboratory Analyzer Parts
Surgical & Medical Instrument Components	Surgical Instrument Handles, Endoscopic Components, Medical Tool Housings, Precision Instrument Assemblies, Orthopedic Instrument Parts
Medical Device Enclosures	Medical Equipment Housings, Device Covers, Portable Healthcare Device Enclosures, Control Unit Casings, Protective Covers
Laboratory & Life Science Components	Laboratory Instrument Components, Sample Handling Fixtures, Fluid Management Components, Test System Assemblies
Wearable Healthcare Components	Wearable Device Enclosures, Health Monitoring Components, Sensor Integration Parts, Portable Healthcare Device Housings
Medical Fixtures & Manufacturing Aids	Assembly Fixtures, Testing Fixtures, Inspection Gauges, Validation Tooling, Production Jigs
Development & Validation Components	Prototype Components, Engineering Validation Units, Design Verification Parts, Functional Testing Components

Medical Device Materials & Manufacturing Processes

Select materials and processes based on function, geometry, sterilization, dimensional stability, production volume, and required documentation.

Materials	Material	Processes	Benefits	Applications
Metals	Aluminum	CNC Machining, Sheet Metal, Metal Casting	Lightweight, easy to machine, and suitable for dimensionally controlled housings, fixtures, and equipment structures.	Device housings, fixtures, equipment structures
Metals	Stainless Steel	CNC Machining, Sheet Metal	Corrosion-resistant and durable. 304 and 316 are common options, with passivation or electropolishing available where required.	Surgical instrument components, laboratory equipment, cleanable hardware
Metals	Titanium	CNC Machining, 3D Printing	High strength-to-weight ratio and corrosion resistance. Biocompatibility depends on the specific alloy, grade, application, and required documentation.	Surgical instrument components, orthopedic development parts, lightweight precision hardware
Engineering Plastics & Elastomers	Polycarbonate (PC)	CNC Machining, Injection Molding	High impact strength with transparent grades available. Sterilization compatibility depends on resin grade, method, cycle count, and molded stress.	Diagnostic equipment, transparent covers, device housings
Engineering Plastics & Elastomers	PEEK	CNC Machining, Injection Molding	High heat resistance, chemical resistance, strength, and dimensional stability, but with higher material and processing cost.	High-performance medical device components, fixtures, precision parts
Engineering Plastics & Elastomers	Silicone	Silicone Molding	Flexible and suitable for seals, soft interfaces, and wearable components. Biocompatibility depends on the selected medical-grade formulation and documentation.	Seals, wearable healthcare products, masks, flexible interfaces
Engineering Plastics & Elastomers	ABS	CNC Machining, Injection Molding, 3D Printing	Lightweight, impact-resistant, easy to machine and finish, and cost-effective for housings and functional development parts. Not suitable for every sterilization or patient-contact requirement.	Diagnostic enclosures, equipment housings, handheld devices, laboratory equipment
Engineering Plastics & Elastomers	Nylon (PA)	CNC Machining, Injection Molding, 3D Printing	High strength, wear resistance, and fatigue performance. Moisture absorption can affect dimensions; glass-filled grades improve stiffness but increase directional shrinkage and warpage risk.	Medical fixtures, guide components, mechanical assemblies, laboratory automation parts
Engineering Plastics & Elastomers	Acetal (POM / Delrin)	CNC Machining, Injection Molding	Low friction, low moisture absorption, good wear resistance, and dimensional stability for precision moving components.	Instrument mechanisms, valve components, sliding parts, precision assemblies

Medical Device Finishing & Secondary Operations

Finishing can affect dimensions, cleanability, markings, and critical mating or sealing surfaces.

	Surface Finishing	Passivation & Electropolishing	Laser Marking	Assembly Services	Ultrasonic Welding	Pad Printing & Silk Screening	Controlled Packaging	Custom Secondary Operations
Applicable To	CNC machined metals and plastics	Stainless steel medical components	Metal and plastic parts	Multi-component medical products	Compatible thermoplastic components	Plastic and metal housings	Finished components and assemblies	Based on project requirements
Primary Benefit	Improve appearance, corrosion resistance, cleanability, or surface condition while controlling dimensional impact	Remove surface contamination, improve corrosion resistance, and create smoother stainless-steel surfaces	Permanent identification, serial numbers, 2D codes, and traceability markings	Reduce supplier handoffs while controlling fit, fastening, and functional assembly	Create repeatable thermoplastic joints without adhesives when the joint geometry is suitable	Add user-interface graphics, instructions, identification, and cosmetic markings	Protect part condition and cleanliness during handling, transportation, and storage	Integrate project-specific finishing, assembly, inspection, or handling requirements
Typical Medical Applications	Device housings, diagnostic equipment, fixtures, instrument components	Surgical instruments, laboratory equipment, fluid-handling hardware	Serial numbers, identification codes, UDI-ready marking applications	Diagnostic devices, wearable products, instrument assemblies	Plastic housings, fluid-management components, disposable device assemblies	Handheld devices, equipment panels, user interfaces	Diagnostic components, medical assemblies, production parts	Specialized prototypes and production programs
Regulatory / Documentation Consideration	Finish specification, chemistry, masking, and dimensional effect should be defined	Material grade and process specification should be confirmed	Customer marking content and verification requirements should be supplied	Approved BOM, work instructions, and test criteria should be defined	Weld validation may be required depending on the application	Ink compatibility, adhesion, cleaning, and durability should be qualified where relevant	Cleanliness, barrier, labeling, or sterility requirements must be specified; packaging does not imply sterilization	Defined by the individual project
Available For	Prototypes & Production	Prototypes & Production	Prototypes & Production	Production & Assembly Programs	Prototypes & Production	Prototypes & Production	Production Programs	Custom Programs

Medical Device Manufacturing Case Studies

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