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Our Design and
Engineering Services

AMDD’s development services are ISO 13485:2016 compliant for design, design remediation, verification and validation. AMDD Risk Analysis processes are ISO 14971:2012 compliant and provide risk analysis at each phase of the development lifecycle.

    Human Factors Engineering

    Human Factors Engineering, Usability Engineering (HFE/UE) report per FDA Guidelines

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    Electrical Engineering

    Advanced electrical engineering and for both medical and consumer products

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    Product Life cycle Management

    Medical Device Remediation, DHF gap remediation, V&V testing, obsolescence design

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    Software Engineering

    Structured software development for medical devices, ISO 62304 compliance

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    Mechanical Engineering

    Robust mechanical engineering, concept development, trouble shooting manufacturing processes and everything in between

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    VALUE-ADDED CONSULTING

    Market analysis, IP management, QMS integration, regulatory strategies, management consulting

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    Client We've Served

    Our success spans a wide range of medical devices, from Class I low risk devices to Class III life support products. We are your partner because of our expertise with the entire design cycle and product lifecycle; from concept to market to product monitoring.

    Our Portfolio

    the agile design process

    Most medical device manufacturers utilize a classic water fall development process. This is a risk –averse, top down approach that does not keep pace with demands of today’s market place.

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    our customers are our partners

    When Agile Medical Device Design partners with you we become vested in your success. Our agile ethos spills into out business culture, and we strive to create a synergy with our partners

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    Iso 13485:2016 compliant quality system

    When Agile Medical Device Design partners with you we become vested in your success. Our agile ethos spills into out business culture, and we strive to create a synergy with our partners

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    Phone Number

    CHI:(224) 585-3870

    IND:(317) 763-0278

    address

    222 Merchandise Mart Plaza Suite 1230 Chicago IL 60654

    12175 Visionary Way Suite #400 Fishers IN 46038

    e-mail

    info@amdd.com

    Agile Medical Device Design (AMDD) follows the ethos of agile development methodology in all engineering disciplines (Human Factors, Electrical Engineering, Mechanical Engineering, Software Engineering and System Engineering) to solve complex medical device development and design challenges.

     

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    AMDD welcomes small projects as well as large ones. We help with all phases of the product development process, from early concept testing to product launch.

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