MEDICAL DEVICE
Medical device manufacturing
from concept to commercialization
From early product design and DFM through tooling, molding, assembly, packaging, and logistics, Alentra brings every capability under one roof — a single-source, concept-to-commercialization model that 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 in-house engineering, tooling, cleanroom molding, assembly, validation support, and quality systems to deliver components and devices to demanding specifications—from development through commercial production.
Discuss your program
Controlled cleanroom manufacturing
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, and specialized inspection support consistent, documented production.
One accountable team
Design, tooling, molding, assembly, and validation support connected across the full program lifecycle.
WHAT WE MAKE
Components and devices for demanding healthcare applications.
Representative applications spanning precision components, single-use consumables, connected devices, and finished assemblies.
Surgical & procedural components
Stents & delivery systems
Single-use devices & consumables
Micro & tight-tolerance parts
Assemblies & finished devices
Connected & traceable devices
Surgical & procedural components
Precision where every component matters. Alentra supports surgical and procedural device programs from early development to repeatable production, with connected capabilities that help meet demanding requirements for fit, function, and consistent quality.
- Design refinement and prototyping
- Precision tooling and tight-tolerance molding
- Cleanroom manufacturing and component assembly
- Packaging, kitting, and sterilization coordination
Stents & delivery systems
Consistency at the scale your program demands. Alentra combines precision molding, cleanroom production, and integrated finishing services to help bring single-use devices and consumables from development to dependable, high-volume manufacturing.
- Injection and blow molding
- Medical-grade material selection
- Automated assembly and in-process inspection
- Packaging, labeling, and sterilization coordination
Single-use devices & consumables
Consistency at the scale your program demands. Alentra combines precision molding, cleanroom production, and integrated finishing services to help bring single-use devices and consumables from development to dependable, high-volume manufacturing.
- Injection and blow molding
- Medical-grade material selection
- Automated assembly and in-process inspection
- Packaging, labeling, and sterilization coordination
Micro & tight-tolerance parts
Small components. Demanding requirements. Alentra brings together precision tooling, micro molding, and dimensional inspection to help produce intricate parts with the repeatability your device needs.
- Micro-sized components and intricate geometries
- Material selection for demanding applications
- Precision tooling and process optimization
- Dimensional inspection and capability studies
Assemblies & finished devices
Bring every part of your program together. Alentra connects component manufacturing, assembly, and final packaging to help simplify production and move your device toward finished-product readiness with fewer handoffs.
- Manual and automated assembly
- Bonding and ultrasonic welding
- Visual inspection and quality checks
- Final packaging, labeling, and kitting
Connected & traceable devices
Build identification into your product from the start. Alentra supports RFID and NFC integration alongside molding, assembly, and labeling to help enable product identification and traceability within your connected device program.
- UHF RFID inlays and NFC tags
- Integration planning and prototyping
- Component assembly and tag incorporation
- Coordinated labeling and 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 regulated markets, 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, with downloadable certificates. - FDA registered & 21 CFR Part 820 / QMSR aligned
Ready for regulated device production and inspection. - IQ / OQ / PQ validation services
Process validation and qualification integrated into development. - Zero-error Quality Policy & Statistical Process Control
Full-dimensional and on-floor inspection with weekly reporting.
Ready to move your next program forward?
Whether you’re in early concept, tooling, validation, or scale-up, we’ll bring together the expertise and capabilities your program needs for its next stage.
Facilities & CAPACITY
U.S. capacity, coast to coast.
With manufacturing and warehousing across the East and West Coasts, Alentra gives programs access to domestic capacity closer to the markets they serve. Anchored by our Auburn, NY operations, our U.S. footprint supports molding, cleanroom manufacturing, assembly, and logistics—helping strengthen supply continuity and keep programs production-ready.
6
Manufacturing Facilities
7
ISO-certified cleanrooms
167
Molding Machines
5
Coast-to-coast Warehouses
Featured program
Swab-device program
Proof in practice
A more controlled path to production.
For a swab-device program, Alentra combined streamlined design, advanced mold construction, and inline part inspection—creating a connected path from development into production.
Design
DFM
Tooling
Molding
Inspection
EXPLORE MORE
Related markets
Tooling
In-house and U.S./APAC hybrid tool builds with on-site machining and 24/7 monitoring.
Explore Tooling
Injection Molding
Tight-tolerance, repeatable injection molding from prototyping through high-volume production.
Explore Injection Molding
Specialty & Micro Molding
Overmolding, insert molding, two-shot molding, micro molding, and microfluidic manufacturing.
Explore Specialty & Micro Molding
Automation & Assembly
Manual and automated assembly, bonding, ultrasonic welding, and device integration.
Explore Automation & Assembly
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.