740 W Collins Ave, Orange, CA 92867
Medical product development

Medical devices, engineered and built under one roof.

Tera helps medical device startups and OEMs move from concept to production-intent parts. We design, prototype, build the tooling and mold your device in-house, so you have fewer vendors and fewer handoffs.

FEA-validated designs Prototypes in as little as 24 hrs In-house tooling & molding
HIGH-RES SLA PROTOTYPINGHigh-resolution SLA 3D printer building a prototype part
FEA stress simulation of a molded component
ITAR RegisteredU.S. State Department (DDTC)
CAGE CodeRegistered federal supplier
ISO 9000 CompliantDocumented quality system
Composites CertifiedComposite Training Center, Cerritos
What we help you build

From handheld instruments
to precision components.

Our engineers have designed products for medical devices and many other industries. We bring the same design, prototyping and manufacturing team to your project from day one.

Device housings & enclosures

Molded and machined housings designed for assembly, sealing and cleaning, with snap fits, bosses and ribs done right the first time.

Handheld instruments

Ergonomic grips and handles, with overmolded soft-touch surfaces and organic 3D modeling for shapes that feel right in the hand.

Precision components

Tight-tolerance machined and molded parts in plastics, aluminum, steel and engineered materials, including clear parts.

Fixtures & test equipment

Assembly fixtures, inspection jigs, test rigs and robotic automation, so your device can be built and checked the same way every time.

Robotic work cell for automated assembly
Clear injection-molded plastic parts
Ultrasonic welding horn and fixture with a welded part
Why Tera for medical

Fewer handoffs. Faster iterations. Fewer surprises.

Design, prototyping, tooling and molding all happen in one building, so design changes don't have to bounce between vendors.

  • Design for manufacturing from day oneWe design with your molding and assembly process in mind, so there's no expensive redesign later.
  • Simulation before toolingFEA checks stresses, snap fits and load paths before any steel is cut.
  • Bridge tooling and pilot runsWe build aluminum molds in-house for fast pilot quantities before you commit to production steel.
  • Overmolding, welding and assemblyWe handle overmolding, inserts, ultrasonic welding and assembly at multi-purpose QC stations.
  • Files you ownYou get native CAD, 2D drawings and BOMs to support your design history and supplier transfer.
Quality & compliance

Built to hold up
to FDA review.

We've supported clients through 510(k) submissions, so we know what your regulatory team needs from engineering and manufacturing.

510(k) support

Engineering data, test samples and documentation packaged to support your 510(k) submission and FDA questions.

Design documentation

Controlled drawings, BOMs, specifications and revision history ready for your design history file and device master record.

QC testing & inspection

First article and in-process inspection, dimensional reports and functional testing on dedicated QC stations.

Process development

Documented molding, welding and assembly processes, with validation support so every lot is made the same way.

Production planning

Capacity, material and schedule planning from pilot builds through production, with lot traceability.

Design transfer

A clean handoff from development to manufacturing, with work instructions and inspection criteria in place.

How we work

From concept to
production-intent parts.

Each phase ends with something you can hold, test and show to investors, clinicians or your regulatory team.

01

Concept & feasibility

We review your user needs, early sketches and constraints, then propose an approach, budget and timeline.

02

Engineering & DFM

We produce detailed CAD, FEA, materials selection and manufacturability reviews for molding and assembly.

03

Prototype & refine

We make SLA, FDM, cast and machined prototypes for fit, form and function testing, then iterate quickly.

04

Tooling & production

We build in-house molds, run pilot and production molding, and handle secondary operations and assembly.

Inside our shop

The equipment behind your device.

In-house capabilities

Everything your device needs.

One partner from the first prototype to the production run.

EngineeringIndustrial design, mechanical engineering, FEA, organic 3D modeling
ElectronicsIntegrated electronics and PCB design, battery-powered and low-power systems, BLE 5.0 and Wi-Fi connectivity, vision systems
Prototyping15 FDM printers (up to 19" × 19" × 19"), 2 high-resolution SLA printers, silicone and urethane casting
Machining5 multi-axis CNC mills (parts up to 6' × 3' × 4'), EDM, surface grinding, laser cutting and engraving
ToolingAluminum and steel injection molds designed and built in-house
Molding17 injection molding machines, overmolding, inserts, live cores, injection blow molding (65–300 ml)
Assembly24 multi-purpose assembly and QC stations, ultrasonic welding, robotic automation

Have regulatory requirements? Our quality system is ISO 9000 compliant. If your device needs ISO 13485 processes, cleanroom molding or specific biocompatible materials (for example USP Class VI or ISO 10993), tell us when you request a quote. We'll tell you plainly what we handle in-house and where we bring in qualified partners.

FAQ

Medical development questions.

Can we start with just a sketch?

Yes. Many of our projects start as a napkin sketch or a rough idea. We turn it into CAD, then into prototypes you can test.

How fast can we get a prototype?

Simple 3D-printed prototypes can often be ready within 24 hours. Machined, cast or multi-part prototypes take longer, and we'll give you a clear timeline with your quote.

Can you produce low-volume and pilot runs?

Yes. Because we build our own molds, we can make bridge or pilot quantities in aluminum tooling, then move to production tooling once your design is locked.

Can you help choose materials?

Yes. We'll recommend resins and metals based on strength, chemical resistance, cleaning and sterilization needs, clarity and cost, and we'll prototype in close equivalents where possible.

Can you support our 510(k) submission?

Yes. We've supported clients through 510(k) submissions. We work alongside your regulatory team or consultant and provide the engineering documentation, test data and samples they need.

Start your medical project

Let's talk about your device.

Share what you're building and where you are in development. An engineer will follow up with next steps and a quote.

  • Free initial consultation and project review
  • Design, tooling and molding under one roof
  • Prototypes in as little as 24 hours

Request a quote

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