White Papers

  • Medtech Makers: Molding for Medical Device Manufacturing

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    PTI’s Process Engineer Manager, Marjan Panevski, and Process Engineer, Randy Kliemann, spoke with MPO Magazine Editor-in-Chief, Sean Fenske, and share insights and discuss the reliability and consistency needed in medical molding. Click here to read the article from Medical Process Outsourcing

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  • The Benefits of Injection Molded Plastics in an EV/AV World

    Over the years, plastic has developed into one of the most critical materials in modern manufacturing. The advancements in plastic injection molding technology have made the entire design and manufacturing process faster, more predictable and precise, thus enhancing the functionality and application capabilities of the plastic materials. Plastic components are the preferred choice for advanced…

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  • Reducing the Life Cycle Cost of Validation: Part 1

    Appropriate Material Selection and Part Design Reliable medical devices and equipment are essential for researchers and doctors to accurately diagnose and treat a wide range of diseases. That is why there is such stringent oversight from the FDA to ensure these products meet the necessary requirements and specifications, such as 21 CFR 820. To ensure…

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  • Reducing the Life Cycle Cost of Validation: Part 2

    Mold Design, Construction, and Protocols In Part One of this series, we covered important details you should consider during material selection and part design in order to reduce the life cycle cost of validation. Specifically, avoiding customized materials and staying true to the basic principles of good plastic part design are essential for reducing the…

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  • Reducing the Life Cycle Cost of Validation: Part 3

    Equipment Selection, Processing, and Maintenance Selecting the most appropriate material and having a well-planned mold design, as discussed in Part One and Part Two of this series, are essential pieces of establishing the long-term success and longevity of your medical device validation. However, without the right equipment, you cannot determine the dependability and repeatability needed…

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