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    Biomedical Engineering and Medical Device Design

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    mesic9029
    This document provides an overview of services offered by Deaton Engineering related to medical device design, validation, manufacturing, and FDA compliance. Key services mentioned include orthopedic and cardiovascular device design, premarket notifications and approvals, computational testing to support regulatory filings, risk-based validation engineering, and manufacturing automation and machine design. Deaton Engineering employs a total quality improvement methodology and partners with clients on engineering solutions to support project initiatives from mechanical design to production scale-up.

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    Biomedical Engineering and Medical Device Design

    Uploaded by

    mesic9029
    78 views1 page
    This document provides an overview of services offered by Deaton Engineering related to medical device design, validation, manufacturing, and FDA compliance. Key services mentioned include orthopedic and cardiovascular device design, premarket notifications and approvals, computational testing to support regulatory filings, risk-based validation engineering, and manufacturing automation and machine design. Deaton Engineering employs a total quality improvement methodology and partners with clients on engineering solutions to support project initiatives from mechanical design to production scale-up.

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    Medical devices

    Original Title

    Medical Devices

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    This document provides an overview of services offered by Deaton Engineering related to medical device design, validation, manufacturing, and FDA compliance. Key services mentioned include orthopedic and cardiovascular device design, premarket notifications and approvals, computational testing to support regulatory filings, risk-based validation engineering, and manufacturing automation and machine design. Deaton Engineering employs a total quality improvement methodology and partners with clients on engineering solutions to support project initiatives from mechanical design to production scale-up.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    78 views1 page

    Biomedical Engineering and Medical Device Design

    Uploaded by

    mesic9029
    This document provides an overview of services offered by Deaton Engineering related to medical device design, validation, manufacturing, and FDA compliance. Key services mentioned include orthopedic and cardiovascular device design, premarket notifications and approvals, computational testing to support regulatory filings, risk-based validation engineering, and manufacturing automation and machine design. Deaton Engineering employs a total quality improvement methodology and partners with clients on engineering solutions to support project initiatives from mechanical design to production scale-up.

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    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 1

    Medical device design

    Cardiovascular device design


    Orthopaedic design
    Medical electronics device design
    Orthopaedic implant design
    Orthopaedic surgical device design
    Surgical instrumentation design & prototyping
    Premarket notification 510(k)
    Premarket approval (PMA)
    Implantable design; spinal, orthopaedic, neurological, dental, &
    cardiovascular
    Human factors engineering & design
    Device master record (DMR)
    Concept development
    User requirements and functional specifications
    Solid models
    Prototypes
    Design for verification and validation
    Development of Class I, Class II, &
    Class III medical devices
    Quality system integration
    Orthopedic device design
    Computational testing
    Identifying worst-case device sizes
    In vivo loading conditions
    Anchoring and fatigue loading conditions
    Design verification and validation
    Medical device engineering
    Medical device product design list
    Engineering services list
    Validation engineering services list
    FDA, regulatory and safety services list
    Biomedical Engineering and Medical Device Design
    Recent advances in technology have opened the door to many exciting new product opportunities for medical device firms. But competitive pressures and strict
    regulatory requirements make it tougher than ever to bring a new product to market. In addition, Medicare and insurance cutbacks on patient reimbursement are
    putting pressure on margins.
    Deaton Engineering applies a risk-based approach to medical device manufacturing. This
    technique can deliver substantial improvements in productivity while maintaining the highest
    assurance of product and human safety. We deliver cost-effective, FDA-compliant solutions by
    assisting you in developing a plan to meet your goals.
    We employ a Total Quality Improvement methodology for design, validation, and manufacturing.
    We partner with you to develop and deliver innovative engineering solutions to support your project
    initiatives, whether it's a mechanical design, a production scale-up, a major automation project, or a
    plant expansion.
    Medical Device Design, Validation, Manufacturing
    Automation, and Machine Design
    Medical Device Design
    Deaton Engineering is experienced with the FDA's requirements for medical devices. We
    incorporate good documentation practices and validation strategies into our designs. We consider
    the impact of the design on manufacturing techniques, cost control, cleaning, and sterilization procedures. Our engineering staff can produce your medical device
    prototypes and provide documentation for 510K submittals, and UL and CE certification.
    Risk-Based Validation Engineering Services
    Deaton Engineering manages the validation process by developing a strategy that includes requirements, risks, and test procedures to ensure compliance with good
    manufacturing practices. Deaton Engineering can develop Installation, Operation, and Performance Qualification protocols for any type of manufacturing process,
    facility or equipment.
    Computational Methods to Support Regulatory Filings for Medical Devices
    Utilize FEA to reduce product development costs, limit liability risk, reduce time to market, and support FDA 510k filings. Identify and analyze worst-case implantable
    device size for use in mechanical testing. Verify radial force, anchoring, dynamic compliance, and fatigue loading conditions.
    Manufacturing Automation & Machine Design
    Deaton Engineering designs fully automated manufacturing systems that incorporate industrial robots, vision systems, and QC testing. We specialize in building
    turnkey process and equipment solutions that are reliable, cost-effective, and GMP compliant.
    Biomedical Engineering & Design Services

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