Sterilization Techniques and Compatibility with High-Performance Medical Plastics

In hospitals, much is demanded of medical plastics. They must be safe, durable, comfortable to handle and cost effective. They must also be compatible with ...
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New Genesis Implantable PEEK Film Opens Application Opportunities in Medical Devices

Cypress, TX, June 20, 2023 — Genesis Medical Plastics now offers its own brand of PEEK film and thin sheet for fabricating intricate components for ...
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Understanding Medical Plastics vs Sterilization Methods

Several polymers have been adopted for widespread use in medical devices, trays, instruments, and other applications used in hospitals, ambulatory surgery centers, as well as ...
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FDA Testing and Approval Processes for Implantable Devices Made from PEEK Polymer – Part 2

Part 2:  The 510k Clearance Process Note: This is Part 2 of a Guide to the FDA Regulatory Processes for Implantable Devices Made from PEEK ...
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FDA Testing and Approval Processes for Implantable Devices Made from PEEK Polymer – Part 1

Part 1: The Premarket Approval Process Note: This is Part 1 of a Guide to FDA Approval and Testing Processes for Implantable Devices Made from ...
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Are Plastics’ Data Sheet Properties Accurate?

Properties reported in suppliers’ data sheets for plastics including medical grades are based on testing industry-standard injection molded ASTM or ISO tensile bars. The tests ...
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What is Biocompatibility?

Before medical device manufacturers can bring a device to market, they must first demonstrate its biocompatibility to the FDA. And from the FDA’s perspective, this ...
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Genesis Medical Plastics Introduces Implantable PEEK Film

Cypress, TX – Genesis Medical Plastics has developed production-scale calendering to convert medical grade and implantable PEEK into thin sheet and film. The technology adds ...
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Key Factors in Selecting Plastics for Medical Devices

Medical device manufacturers have long recognized the advantages plastics offer over metals. The rapid growth of these light-weight, versatile and cost-effective materials in the health ...
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What Are the Stages of Creating a New Medical Device from Biocompatible Polymers?

Medical devices are among the most challenging products to bring to market, and for good reason. While medical devices can solve intractable health problems, they ...
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Are Machining and Fabrication Different Ways To Make Medical Grade Plastic Components?

Plastics machining and plastics fabrication are terms sometimes used interchangeably when referring to ways to make components for medical devices and equipment. Most probably this ...
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Are Plastics A Good Choice For Single-Use Medical Applications

Are Plastics A Good Choice For Single-Use Medical Applications?

Historically, health care facilities used metals or premium high-performance biocompatible plastics for surgical instruments that could be sterilized after each use. More and more, however, ...
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Toll Manufacturing vs. Contract Manufacturing: What is the Difference

Medical devices are in high demand and companies who provide them often compare the efficiencies of toll vs contract manufacturing for the best output of ...
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A Guide To FDA Registered vs Approved Medical Devices

The US Food & Drug Administration (FDA) is the primary regulatory body for medical plastics and the devices they are used to create. According to ...
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Cypress, TX (May 13, 2021) – Genesis Medical Plastics Ltd, experts in medical polymer manufacturing, and Foster Corporation, a leading producer of medical polymer compounds ...
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Implantation Testing

Implantation testing is one of several biocompatibility tests, reserved for medical devices that are placed in the body’s internal tissue, bone or cavities. As such, ...
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