Partnering with ACHB means gaining access to 30+ years of specialized experience in manufacturing high-quality Class I/II medical devices and components. ACHB combines cutting-edge machining technology, injection molding, die casting, and other manufacturing services with deep industry expertise to help your medical devices comply with regulatory standards and beat the competition to market.
Experts in Medical Device Design & Engineering
When you partner with experts who understand the medical device manufacturing landscape, from regulatory compliance to innovative design and rigorous quality testing, our specialized team is dedicated to delivering products that meet the ISO 13485 quality standards for performance, safety, and efficiency.
Our manufacturing processes, from DFM to prototyping and full production, are backed by our ISO 13485 credentials along with FDA registration for medical devices.
ACHB excels at handling the various design complexities and engineering challenges presented by end-to-end medical device manufacturing, setting OEMs up for repeatable success.
All medical device manufacturing projects at ACHB undergo advanced manufacturing testing techniques and exhaustive quality assurance processes to ensure device performance.
ACHB completes FAI, in-process verification, and other documented process validation procedures to confirm dimensional accuracy and repeatability before full production.
Our team uses CMM machines, calibrated inspection equipment, and stringent documentation practices to meet any regulatory requirements for medical devices.
Our end-to-end medical device manufacturing services are backed by our ISO 13485 certification and FDA registration, ultimately producing market-ready devices with fast turnaround times.
QA Guarantees & Regulatory Compliance
The performance, safety, and viability of your medical devices rely on final rigorous testing and quality control before they ever reach a hospital or patient. Our ISO 13485-certified end-to-end medical device manufacturing services ensure that your products meet all regulatory and performance standards. ACHB testing procedures include:
Precision Manufacturing for Medical Devices & Equipment
ACHB supports end-to-end medical device manufacturing across a variety of different devices, equipment, and end applications.
All projects are guaranteed to meet the necessary specifications for precision, quality, and repeatable production from prototype to final production.
Fluid Management Device Manufacturing
We manufacture precision components, sub-assemblies, and full market-ready assemblies for fluid management systems, including infusion systems and dialysis equipment.
Fluid Management Device Manufacturing
Detection & Diagnostic Device Manufacturing
Our manufacturing capabilities for medical OEMS include advanced detection technologies, including diagnostic devices and other patient monitoring sensor systems.
Detection & Diagnostic Device Manufacturing
Automated & Robotic Medical Systems
ACHB provides manufacturing support, including DFM services for advanced medical automation technologies like surgical robotics and automated drug delivery systems.
Automated & Robotic Medical Systems
Temperature Control Device Manufacturing
Our team delivers precision manufacturing solutions for temperature-sensitive medical uses, including complex thermoregulation systems and temperature monitoring devices.
Temperature Control Device Manufacturing
Medical Device Design Experts for End-to-End Production
By partnering with ACHB for your component design needs, you can ensure your designs are optimized for manufacturability, cost efficiency, and scalability, setting the stage for successful production and long-term performance. Contact our team to learn more about how we can support your next project.