Assembly is a key part of medical device manufacturing.
This is where individual components are combined into functional subassemblies and finished products.
As the interface between manufacturing and packaging, assembly has a significant impact on quality, process stability, and supply reliability. It is therefore a critical factor in the consistent production of both OEM and sfm products.
At sfm medical devices, both standardized products and customized solutions for international medical technology markets are assembled.
Efficient Assembly in a Three-Shift Operation
Assembly takes place in a large-scale cleanroom environment operating continuously in a three-shift system.
The assembly area includes:
Manual assembly workstations for complex products
Semi-automated production lines for various product families
Fully automated systems for high-volume production
This structure enables both cost-efficient mass production and the flexible implementation of customer-specific requirements.
Broad Product Portfolio and High Product Variability
Assembly covers a wide range of medical products and components, including:
Products from the nextaro® family
Thermolesion cannulas
Retrieval filters
Skin biopsy punches
Vertebroplasty and kyphoplasty systems
In addition to finished products, subassemblies are manufactured for use in procedure kits and further medical applications.
A significant portion of production consists of customer-specific products, resulting in a high level of product variation.
Cleanroom Assembly with Validated Processes
All assembly processes are performed in an ISO Class 8 cleanroom environment.
Various joining technologies are used depending on the application, including:
Adhesive bonding
High-frequency and ultrasonic welding
Mechanical fastening (screw assembly)
Pad printing for product marking and identification
These technologies ensure stable, reproducible connections for a wide variety of materials and components.
Integrated Quality Assurance
Quality assurance is an integral part of every assembly process.
Inspection methods include:
Automated vision inspection systems
Visual inspections performed by trained personnel
Functional testing
Flow and leak testing
Automated production equipment is also equipped with integrated measurement and inspection systems for continuous monitoring of critical process parameters.
Experience and Process Expertise
In addition to advanced manufacturing technology, employee expertise plays a vital role.
Trained personnel ensure product quality through standardized processes
Setup technicians and process specialists continuously optimize manufacturing workflows
Ongoing training and hands-on experience contribute to stable and reliable processes
This combination supports consistently high manufacturing quality.
Flexible Medical Device Assembly
The combination of manual, semi-automated, and fully automated processes enables highly flexible manufacturing.
As a result, both small production batches and large-volume programs can be realized efficiently and economically.
At the same time, customer-specific requirements can be seamlessly integrated into production.
This makes assembly a key element in scalable and adaptable medical device manufacturing.
Looking for an Experienced Partner for Medical Device or Subassembly Assembly in a Cleanroom Environment?
Contact us to learn more or to discuss your project directly with our team.
