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
- Ultrasound Equipment
- Heart Defibrillators
- Kidney Dialysis Components
- Surgical Lasers
- Diagnostic Optics Manufacturing
- High quality Medical Injectors (needle and non-invasive)
- Molded Enclosures
AUTOMATED VISUAL INSPECTION SYSTEMS
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.
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
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.