Material data sheet
The published Formlabs technical data sheet for the exact material used, so your quality group reviews real numbers.
Home / Medical & Pharma
Built for regulated plantsPuerto 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.
Built for regulated manufacturing
The published Formlabs technical data sheet for the exact material used, so your quality group reviews real numbers.
Critical features measured against the model and written down on every job, not eyeballed at the bench.
Part number, revision letter and material lot recorded for every part, so a deviation investigation has something to read.
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
Dental
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.
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
Quality posture
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.
FAQ
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.
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.
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.
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.
Surgical guides, models and splints on biocompatible resins, printed to your validation.
Read moreFine-feature resin parts, biocompatible resins included, on the Form 4B.
Read morePart numbering, revision control, traceability and the dimensional record on every job.
Read moreSend a photo, the part number if it has one, and the date you need it. We answer in Spanish or English.
Inquire now
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