ABLE Medical Devices is a leader in orthopaedic medical device manufacturing and development, providing standard and complex instruments and implants to orthopaedic, dental, and cardiothoracic original equipment manufacturer (OEM) partners.
The ABLE team brings decades of knowledge in developing and manufacturing direct-to-market products for OEMs. This first-hand experience helps us accurately understand the needs of our customers. We offer an in-depth understanding of regulatory and quality requirements, manufacturing precision and clinical acumen, along with comprehensive market knowledge.
Our dedicated engineering team and world-class manufacturing staff will support your project from concept to full production launch.
Medical implant and instrument development and manufacturing
ABLE Medical Devices develops and manufactures a full range of implants and instrumentation, utilising an integrated quality system. Our experienced team works with OEMs to develop and manufacture solutions for the complex assemblies required for medical device innovation.
Core competencies include:
- Rods and Hooks
- Interbody Devices
- Connectors and Assemblies
- Monolithic instruments
– Drivers, etc.
- Complex instrumentation
- Full system development
- Sterile packed instruments and implants
- Custom packaging and labeling
- OEM line extensions
- Product refreshes
- Design for Manufacturing
Complex instruments and assemblies
ABLE Medical Devices specialises in complex instruments that require more development, engineering, and skill than standard drills or taps. We offer expedited lead times and competitive prices, recognising that complex instruments are often the lynchpin of any effective system.
Wide range of materials and equipment for medical device development
ABLE Medical Devices has an extensive list of equipment to meet your medical device machining needs. By using lean principles, we deliver projects on time while exceeding quality standards.
Our material experience ranges from various grades of steel, aluminium alloys, cobalt chrome, and titanium to polymers such as phenolic, ultra-high-molecular-weight polyethylene (UHMWPE), and polyetheretherketone (PEEK).
ABLE has access to a range of machining methods, including:
- Nine-axis Swiss turning
- Multi-axis machining
- Wire electrical discharge machining (EDM)
- Laser and gas tungsten arc welding (GTAW) welding
- Multi-sensor co-ordinate measuring machines (CMMs)
- Complex assembly
- Laser marking
Regulatory compliance and quality control
ABLE Medical Devices provides quality services and products in line with our guiding principles and operating mechanisms. We are committed to a quality management system that complies with applicable regulations, continuously improves our operations, and meets customer needs.
Our quality objectives are designed to ensure the following:
- Defect-free products and services are shipped or otherwise provided to customers
- Our solutions meet customer needs
- Our quality management system (QMS) processes are continuously improved
- Our company maintains its ISO 13485 certification
About ABLE Medical Devices
ABLE Medical Devices is a portfolio company of The Longyear Company, a privately held asset manager based in Michigan. The Longyear Company has been operating for 145 years across a range of markets and asset classes.