Precision Molds for Medical Devices: Engineered for Reliability and Compliance

At Strengthen, we understand that medical device molds are the foundation of product safety, performance, and patient well-being. We specialize in designing and manufacturing high-precision, high-stability injection molds for a wide range of medical applications, from single-use components to complex device housings.

Why Partner with Us for Your Medical Mold Projects?

• Uncompromising Precision & Quality Control:

  • Our mold design and manufacturing process is governed by strict protocols to achieve micron-level tolerances and exceptional repeatability.

  • We utilize advanced CMMs, optical projectors, and comprehensive inspection systems to validate every detail, ensuring each mold and its produced parts meet exact specifications from the first shot to the millionth.

• Deep Regulatory Understanding:

  • Our engineering team is proficient in designing for manufacturability (DFM) and compliance with critical industry standards, including ISO 13485 and FDA requirements.

  • We provide full documentation and material traceability (as required) to support your regulatory submissions and quality audits.

• Expertise in Medical-Grade Materials:

  • We have extensive experience processing a variety of medical-grade polymers, including biocompatible resins, radiolucent materials, and high-performance plastics that can withstand repeated sterilization cycles (e.g., Autoclave, Gamma, and EtO sterilization).

• Validated for Cleanroom Molding:

  • Our injection molding division is equipped and managed to support the production of components for cleanroom environments, minimizing the risks of contamination.

Our Medical Device Mold Capabilities Include:

• Molds for Single-Use Devices: Syringes, IV connectors, pipette tips, surgical instruments.

• Molds for Diagnostic Equipment Housings: Casing for analyzers, monitors, and portable scanners.

• Molds for Drug Delivery Systems: Components for inhalers, auto-injectors, and insulin pens.

• Molds for Surgical Tools & Handpieces: Durable, high-precision components.

• Molds for Implantable Device Trays & Packaging.

Your Partner from Concept to Clinic

We are more than a mold maker; we are a solution provider. We collaborate closely with you through every stage—from initial design review and prototyping to validation support and full-scale production—ensuring a seamless path to market for your critical medical device.

Let's discuss how our precision molds can bring reliability and efficiency to your medical innovation.