MEDICAL DIAGNOSTICS CONSUMABLES
Auer Precision has provided product support and manufacturing solutions for the medical and life sciences industry for over 25 years. Our Medical Products Group works with customers from initial design and prototyping through full commercial realization, including Tier 1 assembly/packaging and supply chain management. We
specialize in die-cut (stamping) and automated solutions for disposable microfluidic and lateral flow devices. Our facilities are ISO 13485 certified including
class 5, 7 and 8 clean room facilities. Read more about our Medical Device manufacturing capabilities.
At Auer Precision, our core competency focuses on the ability to stamp (die cut) channels and other registration features in multi-layer laminated materials at tolerances at or better than ±.003” to ensure alignment, accuracy and device repeatability. Our systems are designed for cleanliness and can be adapted
for both web-based and card-based applications.
To date, Auer Precision has supported the manufacture of billions of point-of-care strips as well as the stamping of mylar and solupor sheets for high end semiconductor ceramic packages. Consider Auer Precision when laser cutting or other conventional methods approach their limits of accuracy and manufacturability.
Auer Precision has partnered with leading global companies to provide contract manufacturing services for over 40 years. Our reputation and continued demonstration of exceptional competency, quality and organizational strength has allowed Auer Precision to produce critical parts, components and fully packaged product on a sole-source basis to several Fortune 1000 companies.
If your supply chain has become cumbersome, Auer Precision can be your Tier 1 provider of fully-packaged and distributable product. Our technology infrastructure and data capture capabilities support FDA and other regulated data requirements and our organizational depth can facilitate the management and procurement of sub-tier components.
Medical Product Support Capabilities
- FDA Registered Contract Manufacturer
- ISO13485 Accreditation
- Efficient Design & Development Processes
- Tool and fixture Certification Processes
- Validation Support for all Manufacturing Equipment
- Test Method Validation and Gauge R&R for Measurement Equipment
- Key Supplier Management
- Batch Record, Device History Records and SPC Data Management
- On-line, Secure Content and Data Access
Our regulatory and quality engineers provide an integral part of our service offering. From component supply to full Tier 1 assembly and packaging operations, we deliver fully certified manufacturing, regulatory and quality systems for the supply of medical devices.