RESEARCH – DEVELOPMENT – COLLABORATION
We partner with our customers to help transform healthcare.
Equipped with two state-of-the-art Clean Rooms totaling more than 4,000 square feet, AMS provides molding solutions for even the most difficult Class I, II and III medical devices. From tight tolerances and thin walls to high cavitation complex components, our investment in the latest equipment and automation allows us to meet your rigorous standards. This combined with our ISO 13485 certification, makes AMS a solid choice for today’s risk-averse customer.
Comprehensive IQ, OQ, PQ validations are very customer and part specific. They allow us to provide customized solutions for every stage including product development, short runs, and high volume manufacturing. Starting with the Control Plan that documents the overall strategy for the manufacturing process, followed by various reports to ensure nominal dimensions are met repeatedly; we are sure to meet the stringent regulations of the healthcare market. Our team can write these protocols for you or we can implement based on your requirements. Our complete in-house metrology lab allows us to complete these reports accurately.
AMS has partnered with both lab management and sterilization companies alike with outstanding results. Let us manage your project from start to finish. You will only get the best with AMS!
Risk Adverse Reports Include:
- Control Plan
- Change of Process Flow
- Gage R&R
- Gate Freeze Study
- Pressure Loss Study
- Stress Testing
- Viscosity Curve Study
- Statistical Process Control (SPC)
- Process Capability Analysis (Cpk, Ppk)