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Precision Plastic Injection Molders

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Injection Molding: What Are the ISO Standards for Medical Devices?

ISO 13485 on a doctor's clipboard next to medical equipment.

When it comes to making medical products, the functionality of your devices is literally a balance of life and death. That’s why the medical industry relies on standards that govern design, safety, and materials used. Let’s go over the four most common ISO standards for medical devices you should take into consideration during design and manufacturing, as well as the ISO standards and other manufacturer standards you should look for in an injection molding company that will be helping you create the parts for it.

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Getting Started with Plastic Injection Molding for Medical Devices

Blurred image of medical beds and other medical devices in a hospital.

Whether you’re an established business looking to start manufacturing with plastic injection molding or a newcomer to the medical devices industry, it’s important to know how (and when) to start the process of talking to a mold maker and plastic injection molding manufacturer. Unsurprisingly, medical devices are held to a higher standard of quality and manufacturing than most plastic injection parts, so working with someone skilled in that market who understands the standards is vital.

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The Difference Between Normal and Medical Plastic Injection Molded Parts

Medical devices with blurred background in hospital.

We’re proud to be a mold maker and plastic parts manufacturer with many clients from the medical market. For those outside or just starting in the medical industry, it can be surprising how different and rigorous the demands and tolerances for medical plastic injection molded parts is vs. their commercial industry counterparts. Today, we’d like to look at three major places—plastics, QA, and traceability—these parts need to excel at to meet the requirements of the medical industry and patient use.

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Top 3 Industries That Best Utilize Plastic Injection Molding

Truck being loaded by a forklift at a cargo dock.

Plastic injection molding touches on a wide array of industries – after all, if you have a need for polymer parts for your projects and customers, injection molding is one of the best options. However, there are certain industries that have special requirements and, when partnered with the right manufacturer, can best utilize plastic injection molding to not only meet the requirements of their industry but exceed them – especially important in an era of logistical shortages.

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Tips for Better Plastic Injection Molding Parts for the Medical Industry

A hospital room with an MRI machine and several other machines composed of white plastics.

Injection molding manufacturers adhere to very high standards of quality, especially when it comes to producing parts for the medical industry. The plastic components created for medical devices directly impact the health and safety of users and patients alike, so material quality, traceability, and precision are vital areas of focus. To ensure these parts meet the exact specifications and tolerances required of them, manufacturers have to carefully consider several factors during the design phase. Let’s look at some of these tips to achieve better plastic injection molding parts for the medical industry.

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The Benefits of Chemical-Resistant Resins in Medical Plastics

A close-up of an intravenous drip needle and tube with fluid inside.

In times of COVID-19, medical plastics have never been in such high demand. From syringes to face shields, the plastic injection molding industry has had its hands full. Since medical utensils and devices are essential for performing life-saving tasks, not only do they require complex designs and functionality, but they also need to withstand a variety of medical environments, many of which include harsh chemicals and sanitation. To understand the safety precautions applied to injection molding, let’s take a look at the benefits of chemical-resistant resins in medical plastics.

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