Product Manufacturing for the Medical Community
ALTEK is an ISO 9001:2008/AS9100 certified Medical Device Manufacturer (MDM) assisting the Medical industry with Medical Manufacturing Design, Development and Manufacture of critical, FDA compliant medical components and devices created for the OEM market.
Depend on ALTEK’s Medical Manufacturing Process Validation to provide consistent process results and product reliability to help you bring your medical components and medical products to market quickly and safely.
MEDICAL EQUIPMENT MANUFACTURING
Precision engineering, forward thinking, and cutting edge technology allows ALTEK to provide the medical community with sophisticated and high quality equipment for their specialized requirements. Our dedication to provide tailored and reliable products that fulfill the needs of the medical field ensures our customers receive tools that match their applications.
We are proud to be a part of the continued system of maintaining health and quality of life, and are able to provide medical standard equipment as well as custom manufacturing processes. Some of our products include:
- Ultrasound Equipment
- Heart Defibrillators
- Kidney Dialysis Components
- Surgical Lasers
- Diagnostic Optics Manufacturing
- High quality Medical Injectors (needle and non-invasive)
- Molded Enclosures
AUTOMATED OPTICAL INSPECTION SYSTEMS
Reliability in Testing
ALTEK’s Custom Automated Visual Inspection is able to detect product flaws and weaknesses that are invisible to the naked eye, and can be programmed to inspect for thousands of product features.
Our process involves image capturing, programming, data collection, and product inspection to levels that meet the requirements for any high tolerance real world applications.
Our optical resource allows us to amplify the source material for inspection to thoroughly inspect the quality, precision, and integrity of a part. Our image capturing allows us to properly visualize the fine detail of the inspected part for proper analysis. Through programming and system processes we are better able to contrast and compare any entity being inspected, ensuring a higher integrity of data. Data collected allows us to measure all the parameters of a given element and provide an accurate report of our findings. ALTEK ensures high quality service, and high quality parts.
Medical Component Verification
Process Validation is required for most FDA Medical Device Manufacturing of life critical medical components and medical devices. ALTEK's Process Validation ensures our medical manufacturing processes are highly-repeatable and meet the control criteria laid out by the FDA.
CONTRACT MEDICAL ASSEMBLY
In-House and Secondary Services
ALTEK’s Contract Assembly services will help guide the entire design process. We perform a rigorous Design for Manufacturing & Assembly (DFMA) to ensure all components are optimized for medical assemblies. Handle all your manufacturing, assembly and testing needs with ALTEK’s in-house Manufacturing and value-added Secondary Services.
ALTEK'S MEDICAL DEVICE MANUFACTURING INCLUDES:
ALTEK is ISO 9001:2008/AS9100 certified and offers REACH and RoHS compliant manufacturing. Our rigorous supply chain management utilizes BOMCheck as a tool to manage raw materials and supply chain partners for regulatory service.