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Built for regulated plants

Your plant cannot use a part that has no paperwork.

Puerto Rico runs one of the densest medical device and pharmaceutical manufacturing clusters in the world. CETS makes the fixtures, gauges, replacement parts and device prototypes those plants need, in materials that come with a data sheet and a written dimensional record.

Biocompatible resins on Form 4BLot traceabilityNDA and supplier packs signed

Built for regulated manufacturing

What travels with the part, at no extra charge.

Material data sheet

The published Formlabs technical data sheet for the exact material used, so your quality group reviews real numbers.

Dimensional inspection record

Critical features measured against the model and written down on every job, not eyeballed at the bench.

Identity and traceability

Part number, revision letter and material lot recorded for every part, so a deviation investigation has something to read.

Biocompatible options

BioMed resins on the Form 4B for skin and tissue contact applications, with the biocompatibility documentation Formlabs publishes.

CETS supports medical device manufacturing and pharmaceutical plants in Puerto Rico with line fixtures, locating nests, handling trays, go and no go gauges, replacement parts for unsupported equipment, and medical device prototyping in biocompatible resin for design review before tooling. Medical device 3D printing here means the Form 4B, BioMed resins and the record your quality group asks for. Work is quoted, built and documented in English or Spanish, whichever your team runs the floor in.

CETS supports pharmaceutical manufacturing in Puerto Rico and the medical device plants beside it with fixtures, gauges, handling trays and replacement parts that arrive with a data sheet, a part number and a dimensional record.

What we make

For plants like yours.

  • Line fixtures, nests and handling trays that keep product off contaminated surfaces
  • Go and no go gauges for in process checks, marked with part number and revision
  • Replacement parts for equipment the OEM no longer supports
  • Device prototypes in biocompatible resin, for design review before tooling
  • Packaging and tray concepts for validation and stability studies
Medical device components including a handle, connectors and a surgical guide on a blue background

Dental

Four dental applications, printed to your validation.

The same Form 4B and BioMed resins serve dental labs and clinics. The biocompatible resins come with the biocompatibility documentation Formlabs publishes for each one; what that documentation means for your specific application depends on its classification and your own validation.

  • Surgical guides, printed from your planning file on biocompatible resin
  • Dental models for case work, checking and presentation
  • Aligner models, batch numbered so each stage stays in order
  • Splints and occlusal appliances in the resin your protocol names

Regulatory determination for each appliance stays with your team. We supply the part, the material documentation and the dimensional record they need to make it.

The full dental 3D printing page
Gloved hands holding a clear printed device housing beside a yellow instrument

Quality posture

Documented work, stated plainly.

CETS operates to an ISO 9001 roadmap: controlled part numbering, revision control, material traceability by lot, and a written dimensional inspection record on every job. We are glad to walk your quality team through the current documentation package, and to complete your supplier qualification forms.

Regulatory determination for your device stays with your quality and regulatory team. We supply the part, the material documentation and the dimensional record they need to make it.

CETS serves Puerto Rico and the US mainland, with international service available.

Puerto Rico US mainland International

FAQ

Common questions

What documentation comes with a regulated job?

The Formlabs technical data sheet for the exact material, the part number and revision letter, a written dimensional inspection record against the model, and the STEP and native CAD files. There is no extra charge for any of it.

Are your materials biocompatible?

The Form 4B prints BioMed resins formulated for skin and tissue contact applications, with the biocompatibility documentation Formlabs publishes for each one. What that means for your specific device depends on its classification and your own validation.

Where does CETS stand on ISO 9001?

CETS operates to an ISO 9001 roadmap: controlled part numbering, revision control, material traceability by lot, and a written dimensional inspection record on every job. We are glad to walk your quality team through the current documentation package.

Can you sign an NDA and a supplier agreement?

Yes. Send us your NDA or supplier qualification package and we will complete it. Files you send stay confidential and are never used as work samples without written permission.

Bring us the part your line is waiting on.

Send a photo, the part number if it has one, and the date you need it. We answer in Spanish or English.

Inquire now

Send us a plan. We’ll 3D print it for you.

A drawing, a CAD file or a photo of the part is enough to start. We reply with a written quote in one business day.

Prefer to talk? (787) 000-0000 · hola@cetsllcpr.com

We reply within one business day.