DeviceLab's Customers

Why Choose Devicelab?

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Your Medical Device Development Partner

DeviceLab is a medical device design and development company that is ISO 13485 certified and has been in business for over 20 years. We have won an MDEA Gold Medal Award and finalist considerations. Our proven track record of 400+ engagements emphasizes our deep understanding of stringent FDA requirements and ISO standards.

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Benefits of Choosing DeviceLab for Your Project

Medical device product development takes on a tortuous multidisciplinary pathway, involving intellectual property (IP), Engineering Design/Development, Safety and Risk Management, Human Factors/Usability, and interaction with the FDA. Firms must demonstrate Product Safety and Efficacy with objective evidence throughout the engineering/design, manufacturing, and product lifecycle. For an introduction, check out our Medical Device Design Roadmap for a high-level primer.

DeviceLab works best with business entities that understand the regulated landscape in the Medical Device industry. We work with clients with experience in product design/development, patient safety requirements, product launches. Having an understanding of FDA ISO requirements, Software SW, Hardware HW, Firmware FW, and manufacturing documentation facilitate rapid development and results. Knowledge of IEC safety requirements, Verification and Validation process, Laboratory tests: UL, EMI, EMC, Sterilization, and Biocompatibility also help in synchronizing our resources and produce speedy product commercialization.

We Work with Early-Stage to Fortune 100 Companies & Design Medical Devices For:

- Home use

- Point of Care (PDC)

- Hospital Environments

We Give Peace of Mind to Our Clients Through Unmatched Experience & Excellence

Unparalleled Qualifications

  • ISO 13485 Certified (Medical Device Design and Development).
  • 400+ engagements.
  • Gold medal award from MDEA (Medical Design Excellence Awards).
  • 20 years of operations.

Unmatched Experience in Device Design & Development

  • We are expert innovators.
  • Regulatory compliance is in our DNA.
  • We are adept at facilitating lab testing and FDA approval.
  • We perform quick design studies all the way to soup-to-nuts projects.

Always Learning – Staying on the Cutting Edge of Medical Device Design

  • Our designers create outstanding designs by following the latest design trends.
  • Our engineers stay current with the latest medical technologies and design tools.
  • Our proprietary process moves quickly through each phase of development.
  • We adapt easily to changes in the regulatory landscape.
Why We Do Small

See our Medical Device Design Roadmap

Learn the process

What Our Customers Say

CEO Recommendations

  • Winn Hong
    “Dac is a great industrial innovator. I’ve used DeviceLab for the past 5 years on several projects. Dac has been an instrumental partner and an extension to our development team. Thanks Dac”

    Winn Hong ; Co-founder, President/CEO at Varocto, Inc.

    France Helfer
    “At TinyKicks we have a strong and ongoing relationship with DeviceLab and Dac’s organization. DeviceLab is extremely competent, start-up friendly, and responsive. Our partnership is developing even stronger as our Company and products evolve. Our core team of Dac, Donald and Khoi give us a major competitive advantage.”

    France Dixon Helfer ; President & CEO of TinyKicks LLC

  • Robert Case
    “Our development teams have found them easy to work with, providing substantial technical and creative value, on a time and cost effective basis.”

    Robert Case ; President | Robert Case & Associates, Inc.

    Drew Knopfel
    “Creative solutions overcame complex design issues such as a patient weight management system, handicap accessibility and arm translational/rotational movement.”

    Drew Knopfel ; Vice President of Engineering | PharmaSmart International

  • Paul Smith
    “Dac and his team have the creativity, technical depth and dedication necessary to bring new products to market quickly and effectively.”

    Paul Smith ; President | Adapt360 / Inspect2GO

    Michael Favish
    “The entire team at DeviceLab quickly understood our objective, and were proactive in making suggestions “

    Michael Favish ; CEO | Guardion Health Sciences

  • Richard W Henson
    “DeviceLab is an industry leader in the design of innovative and complex projects. We’ve worked together often and I could not find a more exceptional company to work with.”

    Richard W. Henson ; CEO | ResVeRx, Inc.

    Jd
    “I have personally worked with DeviceLab for over 15 years at multiple companies. They have a vast list of experience specifically in medical device design and production.”

    Jay Dinsmore ; President & CEO | Protowest, Dinsmore & Associates, Inc.

  • Jeff Blanton
    “DeviceLab is a go to company for mechanical design projects from concept through manufacturing. I would highly recommend DeviceLab for any mechanical design work.”

    Jeff Blanton ; President | Waypoint Leadership, Inc

    Brigitte Phan
    “DeviceLab was exceptionally resourceful, always ready to have creative solutions for any problem that we encountered.”

    Brigitte Phan ; Patent Agent | Allergan

Featured Medical Device Design & Engineering Projects

  • To schedule a free and confidential initial consultation, use the online contact form on this page or call our office today. Based in Orange County, CA, we are a medical device development and product design firm serving Southern California (Los Angeles, San Diego and Orange County) and medical companies nationwide.

    DeviceLab Inc.
    3002 Dow Avenue Suite 124
    Tustin, CA 92780

    Telephone: (949) 264-8273(949) 427-8000
    Email: engineering@devicelab.com

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