Life Science Division of Enplas Global

Enplas Life Tech
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Medical Device Development

Diagnostics. Bioprocessing. Surgical. And more. Enplas provides precision thermoplastic medical molding and assembly solutions for engineers working on new medical products. For high-quality parts and fast, no-nonsense product launches, trust Enplas with your medical device development needs.

First-Class Engineering

Enplas’s engineering expertise means quality and efficiency for your diagnostic or medical device development. Our high-level DFM services ensure your products are optimized for mass production as early as the prototype stage. Our engineering advice is not limited to basic undercuts and drafts—we make innovative suggestions to significantly decrease your medical device development costs.

Having problems with an existing part? Enplas can assess it to solve or enhance your performance issues.

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Speed to Launch

Our goal is to deliver your plastic diagnostic and medical device components with the speed and quality you demand. How can we do it? By putting everything under one roof in the U.S.: DFM, tool design, in-house tool making, class 7 cleanroom injection molding, production-grade prototyping, and assembly. Quality assurance is performed at every step.

Interested in receiving fast, quality medical device development?

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Stress-Free Partnership

We know that medical device development is a long process. That’s why we work with our clients to solve challenges as a team. When you work with Enplas, a knowledgeable engineer is assigned to your project. He or she provides detailed weekly updates and proactive, honest communication about the status of your project.

Our clients tell us we’re responsive, proactive, and understanding of their needs. Learn more about how Enplas’s experience and partnership can benefit you.

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Our Scientific Process for High Quality Production

Enplas’s scientific development process ensures consistent quality in mass production. Our rigorous process validation protocol ensures that every part coming off the line falls within your project’s strictly-set standards.

  • Design Qualification (DQ)

    1

    Quality Review and DFM

    Enplas reviews part print for quality measurements and risk assessment.  Recommendations will be provided to customer for dimensional changes.

     

    The Enplas Difference: Engineering Expertise.

    In addition to thoroughly making sure the parts are safely and efficiently manufacturable, including FMEA, Enplas has provided out-of-the-box solutions to improve product performance and save costs.

  • 2

    Updated Part Print and Model

    Customer updates the part print and model.

     

    The Enplas Difference: Collaboration.

    When there is a conflict between the current design and moldability, Enplas will collaborate with the client to solve the problem. Enplas understands that medical development takes time; we are your partner through multiple iterations.

  • 3

    Mold Design

    Enplas designs a 3D CAD model of the mold and creates detailed blueprints for mold making. The customer has the opportunity to review and approve the prints.

  • 4

    Mold Manufacturing

    Enplas manufactures the mold in-house.

    The Enplas Advantage: Speed

    Our in-house mold-making capabilities and existing mold bases allow us to quickly deliver hardened steel molds ready for mid-volume production in 3-5 weeks.

  • Installation Qualification (IQ)

    5

    T1 Sampling

    Enplas sets up injection molding equipment and raw materials for initial sampling based on scientific molding methods. The customer receives Test 1 (T1) samples.

  • Operational Qualification (OQ)

    6

    Process Development

    Enplas develops the optimal process of injection molding by conducting design of experiment (DOE) studies. The first article inspection is conducted, and the resulting CpK is submitted to the customer.

  • Performance Qualification (PQ)

    7

    Qualification Process

    Real-life testing of the injection molding process is conducted. The press is run for a prolonged period of time to ensure and finalize the injection molding process. The degree and time spent on this process depends on customer requirements.

    Once PQ is completed, we are ready to supply your parts in large volume.

Download our FREE PDF about Enplas’s medical device development services.

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To learn more about Enplas’s medical device development services, contact us today.

PHONE

(828) 633-2250

FAX
(828) 633-2254

EMAIL
info@enplaslifetech.com

ADDRESS

230 Sardis Road
Asheville, NC 28806

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Enplas Life Tech is ISO 13485:2016-certified. Part of the Enplas family, a global publicly-traded company.

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