Injection Molding — Mold Design, Fabrication and Plastic Injection.
Overview
Engineered Molds, Compliant Manufacturing, Scalable Output
At Alliance Medical Technologies (AMT) we treat injection molding as a precision manufacturing discipline. Leveraging decades of experience in medical molding and assembly, an FDA-registered facility, and ISO 13485 certification, we convert designs into repeatable, traceable components ready for high-quality device assembly and commercialization.
Our services includes part design:
- Mold Design
- Mold Fabrication
- Mold Validations
- Injection and over molding process
Capabilities & Competencies
Key technical capabilities
Design for Manufacturability (DFM)
CAE simulation for flow, shrinkage, and cooling; critical tolerances defined according to end-use; ejection and venting systems optimized to ensure repeatability.
Tooling fabrication
High-precision CNC machining, EDM, grinding, and tool trial runs. Complete tool lifecycle documentation (revisions, preventive maintenance, cavity-specific production records).
Supported technologies
LSR (liquid silicone rubber for medical applications), two-shot molding for multi-material/soft–hard components, vertical and horizontal systems for specific molding and automation requirements.
Medical-grade materials
Selection and qualification of biocompatible and engineering polymers (medical-grade silicone, high-performance resins) with compatibility analysis and extractables testing according to regulatory requirements.
Automation and secondary processes
Robotics for pick & place, automated insert loading, in-line vision systems, and production cells designed to minimize human handling and improve throughput and traceability.
Part & Mold Design
Our engineering team couples DFM best practices with Moldflow analysis and tolerance stack studies to optimize part geometry, minimize secondary operations, and ensure robust manufacturability at scale. We design for cycle efficiency, moldability, and downstream assembly to reduce total cost-of-ownership.
Mold Fabrication & Tooling
We partner with precision toolmakers and manage in-house specifications for cavity counts, steel grades, and thermal control systems. From single-cavity prototype tools to multi-cavity production molds, our tooling programs emphasize thermal balance, dimensional stability, and long service life.
Mold Qualification & Validation
Molds are qualified under controlled conditions to demonstrate repeatable cycle times, dimensional capability, and process window stability. Qualification outputs include baseline process parameters, SPC capability metrics, and initial lot sampling to support controlled ramp to volume.
Clean-Room Molding
AMT supports clean-room molding operations in controlled environments tailored to medical requirements. Our Class-clean facilities integrate filtered material transfer, positive-pressure return plenums, and GMP-compatible handling to meet the expectations of sterile-process assembly workflows.
Engineering Support & Program Integration
Beyond presses and molds, AMT offers full engineering support: design reviews, tolerance analysis, pilot runs, production ramp planning, and vendor management for secondary processes (metallization, laser marking, ultrasonic welding). We operate as an extension of your team providing the technical documentation, change control discipline, and traceability required by regulated programs.
Overview
Process control and quality assurance
Statistical approach
SPC, Cp/Cpk studies, cavity and lot variation monitoring.
Dimensional inspection
First article, lot sampling, CMM for critical features, automated optical inspection for surface defects.
Traceability
Cavity/lot identification, electronic records of molding parameters (pressures, injection/holding times, barrel temperatures), integrated into QMS.
Validation
IQ/OQ/PQ of molding equipment and processes for regulated products; biocompatibility and product-specific mechanical testing.
Added value and resilience
Global footprint
Scalable production through facilities in the US, Asia, and Mexico (3,000 employees worldwide), ensuring supply continuity and optimized logistics through nearshoring.
Design for cost and manufacturability
Optimized cavity layouts, balanced line strategies, and packaging design to reduce logistics costs and accelerate time-to-market.
Regulatory security
Production designed to support regulatory submissions (technical dossier, traceability, change-control documentation).
Our Certifications.
Alliance Medical Technologies is majority owned and supported by a global partner with decades of industry experience and a workforce of thousands around the world. This strategic backing provides the financial strength, technical capability, and operational scale to deliver reliable, compliant, and cost efficient manufacturing services; helping our clients move from design to commercial production with confidence.