Injection Molder 13485

Natech Plastics is the industry-leading ISO 13485 certified injection molder.

We are an ISO-certified, family-owned injection molder who provides engineering, custom injection molding, and contract manufacturing services. Our clients bring demanding applications best served by expert engineers and manufacturers.

Safety and quality are non-negotiable. Abiding by an international industry standard ensures best practice in all practices and aspects of product development.

ISO 13485 ensures that an organization maintains a quality management system for medical devices. Natech earned the ISO 13485 certification and implements it to design, manufacture, assemble, and perform secondary operations of custom injection molded plastic parts for use in the medical industry.

ISO 13485 Improves Customer Quality

We make life better for our customers by continuously developing skills in:

1. Risk Accountability

2. Team Learning

3. Improvement Culture

By implementing the ISO 13485 standard, we are always improving these aspects. Natech’s ISO 13485 certification applies to both the primary contract manufacturing facility as well as the second contract manufacturing facility in New York. Natech has been ISO 9001 certified since 2003 and will continue to maintain the ISO 9001 certification at both contract manufacturing facilities.

Injection Molding in USA

We take pride in being the leading ISO 13485 certified injection molder. All Natech tools and production parts are made in the USA. We run three shifts per day, five days per week, and weekends are run on an as-needed basis.

All our injection molding presses are equipped with servo-driven robotics for high-speed automation.

Clients trust Natech to be the in engineering and manufacturing. Our engineers’ experience includes mold qualifications in medical IQ/OQ/PQ, high volume automation in consumer packaging, and engineering-grade resins and ultra-polymers in electronics.

We have developed hundreds of products and manufacture millions of parts annually for the medical industry. Medical devices include point of care diagnostics, microfluidics, and pharmaceutical drug delivery applications.

Consumer Plastic Molded Products

For the consumer market we specialize in the automated production of high-volume disposables, unit-dose packaging, caps and closures, and over-the counter diagnostics and drug delivery applications.

In the electronics market we draw upon deep experience in comprehensive analysis and testing for evaluation and verification to design and build lighter, more durable electronics components.

As the leading ISO 13485 certified injection molder, our product development projects are managed by a Project Engineer who monitors and controls deliverables and provides regular status updates.

Natech’s development projects are supported by MoldFlow Analysis, a Viscosity Curve, a Cavity Balance Study, a Pressure Window Characterization, a Gate Seal Time Study, and a Cooling Time Study. Natech engineers are masters of insert configuration and design single-cavity R&D molds with steel inserted areas. Interchangeable plates, inserts, and sub-inserts allow for more rapid design iterations at lower cost than creating new molds for each feature variation. SPI Class 103 and 104 molds are constructed from P20 steel and aluminum with hot runners and cold runners.

Production molds are high-cavitation SPI Class 101 and 102 molds constructed from hardened steel. Cold, runner, hot sprue, and hot runner molds are designed with up to 128 cavities.

Precision Plastic Injection Molding

Our precision injection molding options include scientific molding, R&D molding, high-cavitation molding, micro molding, over molding, and insert molding.

Our mold maintenance plan ensures each mold undergoes regular cleaning and review at predefined intervals based upon the number of setups and cycles. Mold inspections, general mold maintenance, major mold maintenance and preventative maintenance are standard operating procedures.

Our mid-to-high-volume automated and semi-automated manufacturing of plastic injection-molded components and assemblies for single-use, metered-dose, and multi-use disposables for the drug delivery, consumer packaging, and diagnostics industries offer high quality at economical value.

Our product finishing capabilities include hot stamping, banding, pad printing, silk screening, flaw coating, conductive painting, cosmetic painting, metalizing, and plating.

Our assembly and joining capabilities include product filling, foil/heat sealing, ultrasonic welding, heat staking, mechanical assembly, pinning & UV/hot melt gluing, custom packaging/kitting, and pouching.

Being the premier ISO 13485 certified injection molder, our services New York, New Jersey, Connecticut, Pennsylvania, Maryland, Florida, California, Oregon, Illinois, Maryland, Massachusetts, Colorado, and Michigan and other regions.