Manufacturing
ATEK Medical is an ISO 13485:2003 certified and FDA registered manufacturer for Class II and III disposable, implantable, and electro-mechanical medical devices. Production is based on a Value Stream Team concept. (Contract Manufacturer #1419629).
The Value Stream Team consists of each functional discipline required to make all decisions at the production level for quality, engineering and operations. The Value Stream Team provides extensive product launch, post launch, and sustained production support using lean manufacturing, risk management, and statistical techniques to implement, monitor, and assess products and processes for required reliability and improvement opportunities.
We live Lean Manufacturing and use the Value Stream Team management method to support each product line. Our value stream teams include the following members:
- VST manager (operations)
- Quality engineer
- Manufacturing engineer
- Quality inspector(s)
- Technician(s)
- Assembly team leader(s)
- Assembly team members
- Financial representative
We possess extensive assembly capabilities that our Value Stream Teams use to produce high quality products with a high level of customer service. Assembly expertise includes:
- Difficult hand assembly (with magnification as required)
- Semi-automated and automated assembly
- Electro-mechanical assembly
- CNC – machining
- Solvent bonding
- UV bonding
- Ultrasonic welding
- Silicone bonding
- Catheter tip cutting and forming
- Mandrel dipping
- Cable crimping
- Pad printing
- Laser marking
- FFS packaging
- Tray sealing
- Bar sealing
- Artwork and label creation, printing, and finished good labeling