Medical

A Plan to Help You Save Lives

We understand the pressures, requirements and regulations of medical manufacturing. Just as important, we know the value of finding better ways to get to market faster with breakthroughs and improvements to proven products. Medical Manufacturing requires a constant focus on staying ahead. Hi-Tech’s Medical Manufacturing team has the right prescription for success. Our ISO 13485 certification is only the beginning. Our engineers work with you to find the most efficient, precise and repeatable ways to manufacture your ideas.

Handling the Details

We manage annual FDA visits and maintain registration with the FDA to ensure compliance and product acceptance. We also maintain Medical Device history on components and assemblies, so if there is ever a question, you have the answer. We perform in-process inspection on criticals and generate capability studies using Minitab, which travels with the Certificates of Conformance (CofC).

Capabilities for Medical Manufacturing

Our combination of up front design support and post molding value added services are what sets us apart. We start with unmatched injection molding expertise to create the perfect part. Then we add a plethora of post molding services to save our customers time and money. Our capabilities include:

The Challenge: Manufacture a Proven Product Line Without Supplied Tooling

Long-time customer Primo Medical Group asked Hi-Tech to partner on an RFQ for a product line that was purchased by one of their clients. Hi-Tech would be manufacturing parts for an Intrauterine Endometrial Ablation System. These devices are used in a precise and delicate procedure to remove a thin layer of tissue that lines the uterus.

Reverse Engineering

Controlled environment and white room molding areas
(<100,000 particulate count)
Injection Molding of components and in-line assembly.
Finished Good Packaging for dock-to-stock programs.

Pad Printing and Ultrasonic welding to finish components or assemblies
Generation of OEM Bar Code Labels and Advanced Shipping
Notices via OEM Portal.
Installation Qualification/Operational
Qualification/Performance Qualification