Modern procurement of drawing parts
ISO 13485-Certified Manufacturing for Medical Devices
FACTUREE offers contract manufacturing of medical devices in Germany and worldwide. With us, you have access to processes, materials, and surface finishes. Our certified manufacturers deliver components with complete documentation.
Certifications
ISO 9001 |
ISO 13485Material Certificates 3.1 in accordance with EN 10204 | EMPB
Process Validation According to IQ|OQ|PQ
Why FACTUREE Is Your Partner for Medical Technology Manufacturing
FACTUREE is your manufacturer of medical technology components. We manufacture medical components for surgical instruments, medical devices, diagnostic and laboratory systems, and orthopedic applications. With tolerances as tight as 0.01 mm, full traceability, and complete manufacturing from a single source.
CNC machining, laser cutting, laser welding, and additive manufacturing are all part of our service offerings. Our ISO 9001- and ISO 13485-certified network processes the materials needed by medical device manufacturers, whether it’s 1.4441, Ti-6Al-4V ELI, or PEEK.
Your advantages at a glance:
- Contractual partner with full liability: As the sole contractual partner, we bear full responsibility. We do not act as an intermediary, but as a direct, auditable supplier. You have a single point of contact instead of many individual suppliers.
- Data security & IP protection: We adhere to the ISO 27001 standards to protect your CAD data. Through strict anonymization, manufacturing partners never know which medical device they are producing.
- Full service documentation: For contract manufacturing of medical devices, we handle production, surface treatment, testing, and documentation. If needed, we can also supply the materials. You will receive all the documentation required for your quality management system and technical documentation in accordance with the MDR, initial sample test reports, and complete traceability.
- Security of Supply: Our anti-single-source strategy ensures your supply throughout the entire—and often lengthy—product life cycle of medical devices.
- From prototype development to mass production: Scalable manufacturing solutions with consistent quality. Prototypes and production runs in 9–12 days. No need to switch suppliers all the way through to mass production.
Your One-Stop Shop for Custom Manufacturing of Medical Devices
Applications in Medical Technology
Our medical technology manufacturing covers all key areas, ranging from medical instruments and medical equipment to diagnostics and orthopedics. Here you’ll find a selection of medical technology components that you can have manufactured by FACTUREE.
Surgery & Instruments
- Handles, Shafts, and Functional Parts as CNC-Milled and Turned Parts
- Components for Minimally Invasive Instruments
- Laser-cut and laser-welded instrument parts
- Screens, Trays, and Holders for Processing
Medical Devices
- Enclosures & Front Panels for Medical Devices
- Chassis and panels made of laser-cut sheet metal
- Frames, Brackets & Mounting Plates
- Heat Sinks & Mechanical Components for Electronic Assemblies
Diagnostics & Laboratory
- Precision Parts for Analytical Instruments & Laboratory Automation
- Valve Blocks & Fluidic Components
- 3D-Printed Sample Holders & Positioning Units
- Mounts for Optics & Sensors
Orthopedics, Dentistry & Robotics
- Orthotic and Prosthetic Components, Including Those Produced via Additive Manufacturing
- Components for Dental Equipment & Laboratory Equipment
- Joint and Drive Components for Surgical Robotics
- Test Fixtures & Prototypes for Implant Development
Materials
Our Materials for Your Medical Technology Manufacturing
When it comes to manufacturing medical devices, the right material is key. FACTUREE processes the full range of medical materials—FACTUREE processes many medical materials. These include steels for implants and instruments, titanium alloys, and sterilizable high-performance plastics such as PEEK and PPSU.
Each material is selected based on your component’s requirements for biocompatibility, sterilizability, and strength. The appropriate manufacturing process—whether CNC machining, laser processing, or 3D printing—is also taken into account. Here is an overview of selected materials.
Frequently requested materials
Stainless Steels for Medical Applications
Stainless steels are the standard material for surgical instruments and many device components. They are corrosion-resistant, easy to clean, and suitable for repeated steam sterilization. Stainless steel can be machined, laser-cut, and laser-welded with precision.
Frequently requested:
- 1.4441 (316LVM)
- 1.4404 (316L)
- 1.4021 / 1.4034
- 1.4542 (17-4PH)
- and much more.
Titanium alloys
Titanium offers a unique strength-to-weight ratio, outstanding corrosion resistance, and excellent biocompatibility. Machining titanium is challenging and requires specialized expertise. In medical technology, titanium is processed both through machining and 3D printing. For implant applications, the ELI grade in accordance with ASTM F136 is the standard.
Frequently requested:
- Grade 23 (Ti-6Al-4V ELI)
- Grade 5 (Ti-6Al-4V)
- Grade 2
- Grade 4
- and much more.
High-performance plastics
Medical-grade plastics are lightweight, chemical-resistant, and, in some cases, radiolucent. Materials such as PEEK and PPSU can withstand repeated hot-steam sterilization. They replace metal in applications where weight or imaging are important considerations. FACTUREE processes medical-grade semi-finished products with certifications such as USP Class VI or ISO 10993 from the manufacturer.
Frequently requested:
- PEEK
- PPSU
- PEI (Ultem)
- POM
- and much more.
Aluminum & Specialty Materials
Aluminum combines light weight with excellent machinability. It is ideal for device housings, frames, and mounts, and is often anodized. Silicone is used for seals and soft components. Medical device manufacturers use these materials for medical equipment, laboratory systems, and diagnostic systems.
Frequently requested:
- 6061
- 6082
- 7075
- Silicone (LSR)
- and much more.
Surface treatments
Our Surfaces for Medical Technology
In medical device manufacturing, surface properties determine a component’s corrosion resistance, cleanability, and reprocessability. FACTUREE performs the full range of standard-compliant treatments. These include passivation, electropolishing, heat treatment, and laser marking for direct UDI marking.
Each treatment is specifically selected based on the material, operating conditions, and regulatory requirements of your medical device. Here is an overview of selected processes.
Frequently requested surface treatments
Corrosion Protection & Purity
- Passivation—for stainless steel and titanium, e.g., in accordance with ASTM A967
- Electropolishing – smooth, easy-to-clean stainless steel surfaces, e.g., in accordance with ASTM B912
- Pickling – Removal of Oxidation Stains After Laser Welding
- Ultrasonic Cleaning – for Precision Parts Before Assembly and Packaging
Coatings & Color Coding
- Anodizing – Corrosion Protection and Color Coding for Aluminum Housings
- Titanium Color Anodizing – Color-Coding Instruments Without Dyes
- PVD and DLC Coatings – Wear Protection for Moving Instrument Parts
- Powder Coating – for Equipment Enclosures and Panels
Heat Treatment
- Hardening & Tempering – for martensitic tool steels such as 1.4021 and 1.4034
- Precipitation-Hardening Grades – for 17-4PH (1.4542)
- Stress-relief annealing – after welding, 3D printing, and machining
- Vacuum Hardening – Without Oxidation or Scale Formation
Surface Finish
- Vibratory grinding - deburring & surface smoothing
- Glass Bead Blasting – Matte, Glare-Free Instrument Surfaces
- Polishing – until a high-gloss finish is achieved
- Post-processing of 3D-printed parts – removing support structures, smoothing, and sandblasting
Labeling & Special Treatments
- Laser Marking – Permanent Data Matrix Codes for UDI Direct Marking
- Laser Engraving – Scales, Logos, and Part Numbers
- Cleaning according to customer specifications—before packaging or sterilization
Your applications in safe hands
Quality management & documentation according to IATF 16949
In medical device manufacturing, quality is a requirement that must be documented. FACTUREE ensures that your components meet regulatory requirements. Every step—from prototyping to mass production—is documented.
- Certifications: FACTUREE collaborates with partners in the medical technology sector who are certified to ISO 13485. This enables us to meet the requirements you, as a medical device manufacturer, have for the selection and monitoring of your suppliers.
- Regulatory documentation: We provide support for your technical documentation in accordance with the EU MDR Regulation 2017/745 and QMSR. To this end, we provide material certificates, test reports, and declarations of conformity for RoHS and REACH.
- Sampling & Traceability: First-article inspection reports prepared according to your specifications and measurement reports to ensure a smooth approval process. Every component is fully traceable from the material batch through to delivery.
- Material & Laboratory: We provide material certificates in accordance with DIN EN 10204, Section 3.1.
- Confidentiality: We anonymize your drawings and protect them through NDAs with all manufacturing partners. Upon request, we can provide an NDA immediately or develop a customized agreement.
- Framework Agreements: Customized framework agreements ensure long-term price stability and planning certainty. This makes them ideal for mass production in the medical technology sector.
Contact person
Our Experts for Your Medical Technology Manufacturing
In medical technology manufacturing, precision and traceability are non-negotiable. FACTUREE combines the speed of digital procurement with the technical expertise of our in-house specialists. We conduct a technical review of your drawings and ensure your requirements are met through a robust inspection system. Deliveries are traceable and come with complete documentation for your supplier evaluation.
Our specialists are well-versed in the properties of medical-grade materials and will personally guide you through the entire manufacturing process for your medical device—from prototyping to on-time delivery of your production run. This gives you an experienced point of contact with genuine manufacturing expertise. That’s the difference that matters in medical device production.
Billy Schulz
Head of Operations
schulz@facturee.de
Tel: +49(0) 30 629 3939-0
Antonio Scala
Team Lead
antonio.scala@facturee.de
Tel: +49(0) 30 629 3939-30
Further services
All manufacturing processes from a single source
From CNC machining to additive manufacturing—FACTUREE offers the right process for medical device components that must function reliably. Tolerances as tight as 0.01 mm, complex geometries, and high surface finishes in accordance with medical device quality standards.
What our customers ask
Frequently Asked Questions About Manufacturing in the Medical Technology Industry
Is FACTUREE certified for manufacturing medical devices in accordance with ISO 13485?
FACTUREE manufactures medical device components in collaboration with ISO 13485-certified partners from a network of over 2,000 manufacturing facilities.
Our quality management system is certified to DIN ISO 9001. You will receive a quote, a point of contact, and a delivery.
Does FACTUREE offer prototyping services for medical technology?
Yes, for prototype manufacturing in the medical technology sector, FACTUREE offers CNC machining, sheet metal fabrication, casting, and 3D printing. You can often receive functional prototypes, instrument components, or device housings within 9 to 12 days with tolerances as tight as 0.01 mm. Learn more about prototyping at FACTUREE here.
Does FACTUREE offer 3D printing for medical technology?
Yes, through our network, we provide additive manufacturing services for the medical technology industry. We offer plastics and metals, such as titanium and stainless steel.
In the field of medical technology, 3D printing is particularly well-suited for prototypes, jigs, orthotic components, and complex geometries. For mass production, we’ll work with you to determine whether 3D printing, CNC machining, or injection molding is more cost-effective.
Learn more about 3D printing at FACTUREE here.
Does FACTUREE offer laser cutting for the medical technology industry?
Yes, FACTUREE offers laser cutting services for the medical technology industry. Using laser cutting, FACTUREE manufactures housings, chassis, front panels, and instrument parts made of stainless steel, aluminum, and titanium. Combined with bending, surface treatment, and documentation, you receive ready-to-install sheet metal parts from a single source. Learn more about laser cutting at FACTUREE here.
Does FACTUREE offer laser welding for medical technology?
Yes, FACTUREE offers laser welding for the medical technology industry. Through specialized partners, we perform laser welding on stainless steel and titanium components. Upon request, pickling, passivation, or electropolishing can be performed immediately afterward.
Can I have milled parts for medical technology manufactured at FACTUREE?
Yes, FACTUREE manufactures CNC-machined parts for medical devices and instruments. These include housings, mounts, and valve blocks made of EN AW-6082 aluminum, 1.4404 stainless steel, titanium, and PEEK. All CNC parts come with a 3.1 material certificate in accordance with EN 10204, a first-article inspection report, and complete traceability of material batches upon request. Learn more about CNC milling at FACTUREE here.
What is contract manufacturing for medical devices—and what does FACTUREE handle?
In contract manufacturing, medical device manufacturers outsource the production of their components to a contract manufacturer. FACTUREE handles manufacturing, surface treatment, testing, and documentation. Responsibility for the medical device and its approval remains with you as the manufacturer.
Where can medical technology manufacturers in Germany find a manufacturing partner with short-notice capacity?
At FACTUREE. That’s because FACTUREE is a supplier and contract manufacturer for medical technology manufacturers in Germany, Europe, and around the world. Thanks to parallel production capacities within our network, we can produce prototypes and small production runs in 9 to 12 days.
Does FACTUREE also handle mass production in the medical technology sector?
Yes, FACTUREE supports you throughout the entire process—from prototyping through small-batch production to mass production—without requiring you to change suppliers. We work with ISO 13485-certified partners. We provide standardized quality documentation and offer framework agreements upon request.
Learn more here about mass production and framework agreements at FACTUREE.
What materials does FACTUREE use in the production of medical devices?
Frequently requested materials include stainless steel (1.4441, 1.4404, 1.4021, 1.4542), titanium (Grade 23 ELI, Grade 5, Grade 2), high-performance plastics such as PEEK, PPSU, and PEI, as well as aluminum and silicone. Always specify the material using its full standard designation. Material certificates according to EN 10204 3.1 are available upon request. Learn more about the variety of materials available at FACTUREE here.
Does FACTUREE offer passivation, electropolishing, and other surface treatments all under one roof?
Yes, FACTUREE coordinates heat treatment and downstream processes such as passivation, electropolishing, anodizing, or laser marking through a single request—with standardized quality documentation. Click here to see all surface treatments available at FACTUREE.