Healthcare · medical devices · imagingOur medical
expertise.

Injection-molded plastic parts and machined parts for medical device manufacturers: two ISO 13485:2016 certified sites, qualified processes and lot-by-lot traceability, from prototype to production.

Discuss your device Our certificates

2: ISO 13485:2016 certified sites
1,500 m²: dedicated to machining metal and plastic devices
120,000: implants delivered

Coordinate measurement of machined acetabular cups at Precimade

Molding, machining, industrialization: under one quality system.

Depending on your device, the part is molded, machined, or both. The group’s engineering office steps in upstream to make design and industrialization robust.

Plastic injection molding
Factory Plast · La Baume-d’Hostun, Drôme
- Single-shot and two-shot molding, 35 to 450-metric-ton presses
- Insert overmolding
- Technical parts for medical devices
- ISO 13485:2016 certified (BSI)
Precision machining
Precimade · Bourg-en-Bresse, Ain
- Metal and plastic machining: Swiss-type turning, milling
- Non-sterile implants and instruments
- Finishing, marking and cleaning
- ISO 13485:2016 certified (TÜV Rheinland)
Design and industrialization
Origin 3D · Décines-Charpieu, near Lyon
- Mechanical design and material selection
- Prototypes and first articles
- Tooling and inspection equipment
- Support through to production

Implants and instruments machined by Precimadeprecimade.com (opens in a new tab)

Medical imaging.

For imaging equipment, Factory Plast molds radiation protection parts in custom-formulated engineering materials based on PA or PA 12. The group also produces molded or machined technical components for this equipment.

Quality, measured and traced.

Every process is qualified before production, and every lot delivered can be traced back to its material and inspection records.

Inspection equipment

Coordinate measuring machines
Roughness tester
Non-contact vision
Tensile testing
Dedicated gauges developed for your parts

Methods

IQ / OQ / PQ qualification
FMEA
8D problem solving

Coordinate measurement of parts at Precimade (11-second video, 2023).

Medical certifications.

The ISO 13485:2016 certificates of our two sites, with their exact scope and validity date.

ISO 13485:2016

Factory Plast · BSI · MD 748777

Manufacture of injection-molded technical plastic parts for medical devices

valid until April 4, 2028
Download the certificate ISO 13485:2016 Factory Plast (PDF)
ISO 13485:2016

Precimade · TÜV Rheinland · SX 1541111-1

Contract manufacturing of non-sterile implantable medical devices

valid until April 28, 2027
Download the certificate ISO 13485:2016 Precimade (PDF)

Our regulatory role.

Our companies act as contract manufacturers for medical device manufacturers. Under Regulation (EU) 2017/745 (MDR), the customer remains the legal manufacturer of the device: we produce its parts to its specifications, under our ISO 13485:2016 certified quality management system.

Precimade is registered with the FDA as a contract manufacturer and was inspected by ANVISA (Brazil) in June 2025. Current certificates and statements are available on request.