MEDICAL DEVICE
From first design to finished device, one CDMO partner
As a full-service CDMO, Alentra supports every stage of your device's life, from product design and DFM to tooling, molding, assembly, packaging, sterilization management, and logistics. One partner reduces handoffs and keeps your program moving.
MEDICAL DEVICE
From first design to finished device, one CDMO partner
As a full-service CDMO, Alentra supports every stage of your device's life, from product design and DFM to tooling, molding, assembly, packaging, sterilization management, and logistics. One partner reduces handoffs and keeps your program moving.
WHERE QUALITY IS NON-NEGOTIABLE
Manufacturing the components healthcare depends on.
Medical device programs demand control at every stage. Alentra connects engineering, tooling, cleanroom molding, assembly, validation support, and quality systems to deliver Class I, II, and III medical device components and devices to demanding specifications, from development through commercial production.
Controlled cleanroom manufacturing
ISO Class 7 and 8 cleanroom molding and assembly for healthcare components and devices.
Quality built into the process
An ISO 13485:2016 quality management system, statistical process control, in-line inspection, and full product traceability support consistent, documented production.
One accountable team
Design, tooling, molding, assembly, and validation support connected across the full program lifecycle.
PRODUCTS WE'VE MADE
Components and devices built for demanding healthcare programs.
Examples spanning precision components, single-use consumables, connected devices, and finished assemblies.
Stent devices
Catheter & minimally invasive devices
Surgical devices & components
Cardiac & emergency room products
Single-use disposables
Flexible endoscopy & implants
Stents Devices
Precision for devices that work inside the body. Alentra has produced sinus stent devices and vein stent/bypass devices for Class I, II, and III medical device programs.
- Design refinement and prototyping
- Tight-tolerance and micro molding
- Cleanroom manufacturing and assembly
- Packaging and sterilization coordination
Catheter & minimally invasive devices
Built for complex, minimally invasive procedures. Alentra supports catheter-based and minimally invasive surgical devices with engineering, precision components, and controlled assembly.
- Catheter design and development
- Insert molding and overmolding
- Precision mechanical and sub-assembly
- Cleanroom assembly and packaging
Surgical devices & components
Precision where every component matters. Alentra produces surgical devices and medical components that require tight tolerances and consistent quality.
- Tight-tolerance injection molding
- Micro molding for miniature features
- Manual and automated assembly
- Vision and inline inspection
Cardiac & emergency room products
Reliable components for critical care. Alentra manufactures cardiac and emergency room products in controlled cleanroom environments.
- ISO Class 7 and 8 cleanroom molding
- IQ/OQ/PQ validation
- Cleanroom assembly and kitting
- Labeling and serialization support
Single-use disposables
Consistency at high volume. Alentra produces single-use disposables and consumables with automated, repeatable processes built for medium- to high-volume production.
- Tight-tolerance injection and blow molding
- Pellet-to-pallet automation
- Statistical process control
- Cleanroom packaging and kitting
Flexible endoscopy & implants
Expertise for advanced device programs. Alentra's engineering team has deep experience with flexible endoscopy devices and implants, from development through manufacturing.
- Product design and development
- Design verification and validation
- Precision assembly
- Cleanroom packaging
HOW WE BUILD IT
The capabilities behind your device
Specialized capabilities working together from quality planning through manufacturing and commercialization.
Engineering-led
Concept, DFM, and prototyping tuned for regulated device programs.
Injection Molding
Tight-tolerance, validated molding for device components
Specialty & Micro
Micro and multi-shot molding for miniature device features.
Cleanroom Manufacturing
ISO Class 7 & 8 environments for healthcare components.
Automation & Assembly
Welding, bonding, and kitting into finished devices.
Sterilization Management
Validated sterilization for market-ready devices.
QUALITY & COMPLIANCE
Quality systems built for regulatory confidence.
In medical device manufacturing, quality has to be more than a claim. Our ISO 13485 quality management system, FDA registration, validation services, and inspection capabilities provide documented support from development through production.
- ISO 13485:2016 quality management system
The core medical-device quality standard, applied across our operations. - FDA registered
Supporting regulated medical device production. - IQ / OQ / PQ validation services
Process validation and capability studies integrated into development. - Statistical process control & inspection
Full SPC, full-dimensional and on-floor inspection, and weekly reporting on corrective actions.
Ready to move your next device program forward?
Whether you're refining a concept, validating a process, or scaling production, we'll bring together the expertise and capabilities your device needs for its next stage.
Locations
U.S. capacity,
coast to coast.
With manufacturing and warehousing across the East and West Coasts, Alentra gives medical device programs access to domestic capacity closer to the markets they serve. Our U.S. footprint supports cleanroom molding, assembly, packaging, and logistics, helping strengthen supply continuity and keep device programs production-ready.
6
Manufacturing Facilities
7
ISO-certified cleanrooms
167
Molding Machines
5
Coast-to-coast Warehouses
EXPLORE MORE
Related markets
Drug Delivery
Autoinjector pens, drug-delivery devices, and single-use consumables manufactured with the precision, repeatability, and scale these programs demand.
Diagnostic
Diagnostic cartridges, reagent labware, centrifuge bottles, and high-volume single-use consumables, including microfluidic components.
Pharmaceutical
Ophthalmic bottles, dropper tips, dosing containers, and closures manufactured for pharmaceutical primary packaging.
Life Science
Pipettes, blood-testing components, media bottles, and bioprocess single-use systems and consumables.
Ready to move your program forward?
Whatever your market or stage of development, Alentra brings together the expertise, quality systems, and manufacturing capabilities needed to move your program from concept through production.