Frequently asked questionsWhat our customers
ask us.
Quality, regulations, quotes, materials, precision: short answers to the questions buyers and quality departments ask before entrusting us with a part.
Quality and regulatory
Is Precimade ISO 13485 certified?
Yes. Precimade is certified to ISO 13485:2016 by TÜV Rheinland LGA Products, which is also Notified Body no. 0197 under Regulation (EU) 2017/745. The certificate (ID 0000068876) can be verified on Certipedia and is available on request.
Can you manufacture for the United States and Brazil?
Yes. Precimade is an FDA-registered establishment as a contract manufacturer (no. 3011943495). It was inspected by ANVISA in June 2025 (RDC 665/2022) with no nonconformities.
Who is the legal manufacturer of the medical device?
You are. Precimade acts as a subcontractor within the meaning of Regulation (EU) 2017/745 and supplies the elements of your documentation: lot file, first article inspection (FAI) reports, material certificates and process qualification.
How is traceability ensured?
From the heat of the bar to the delivered part: material lot, work order, machine, operator, measurements, then UDI laser marking. Everything is compiled in the lot file provided with each delivery.
What is a 3.1 material certificate?
It is the inspection certificate defined by EN 10204. The bar supplier certifies in it, under the responsibility of its quality department, the composition and properties of the heat delivered. Every material lot enters our shop with this certificate.
Projects and quotes
What should I send to get a quote?
A dimensioned drawing in PDF and the 3D file (STEP, IGES or Parasolid). Also state the material, quantities per lot, target date and, if possible, the device class and the required treatments.
Send a drawingHow quickly do you reply?
You receive a first reply within 48 hours: feasibility, questions about the drawing or a quote.
Do you sign a non-disclosure agreement?
Yes, before your drawings are opened. Simply check the option in the quote form: we send you the agreement before any review.
Do you make prototypes and small runs?
Yes. We produce from a single part, with no maximum quantity. Prototypes can be validated by 3D printing at Origin 3D, then machined in the final material on our 5-axis centers.
Prototypes and first articlesCan you machine material that we supply?
Yes. Customer-supplied material is accepted and inspected on receipt, then traced like our own lots.
Technical
Which materials do you machine?
Titanium Ti-6Al-4V ELI, 316LVM and ISO 5832-9 (M30NW) stainless steels, CoCrMo, implant-grade PEEK and UHMWPE, instrument steels (1.4123 – X15TN, 1.4543 – MX455, 17-4PH) and polymers such as PPSU. Details are in our material data sheets.
See the material data sheetsWhat precision can you hold?
Down to ±3 µm on critical dimensions, with machines capable of ±2 µm. These dimensions are inspected on a coordinate measuring machine (1.5 µm uncertainty) or on the Keyence LM-X (±1 µm): the tolerance range stays at least four times larger than the measurement uncertainty (ISO 14253-1). Achievable precision depends on diameter and material: our tolerance guide details these limits.
Read the tolerance guideDo you handle finishing and cleaning?
Yes, in-house: bead blasting, vibratory finishing, polishing, electropolishing, passivation, laser marking and robotic cleaning. Anodizing, heat treatment and welding are subcontracted and inspected on receipt.
See our equipment and finishingCan you take care of design?
Yes, with the Origin 3D engineering office, a group company: design in CATIA, SOLIDWORKS, NX and Inventor, dimensioning review, tooling and inspection fixtures.
Do you also make injection-molded plastic parts?
Yes, within Processus Group: Factory Plast performs injection and two-shot molding of technical plastic parts, with a cleanroom.
Your question is not here?
Write to us or call us: we answer you directly.