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We have particular expertise in these 4 branches of medical device design.

Why Choose Devicelab?

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We work with early-stage to Fortune 100 companies and design devices for:

- Home use

- Point of Care (PDC)

- Hospital Environments

YOUR MEDICAL PRODUCT DEVELOPMENT PARTNER

DeviceLab is a medical device design and development company which 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.

Check out these pages:

Recommendations page to see who has been benefitted in working with us

Portfolio page to see our latest projects

Media page for timely content about the medical device industry

ARE WE A GOOD MATCH FOR YOUR PROJECTS?

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.

Why We Do It Best? We give Peace of Mind for our Clients.

  • Device Lab Process Page. See how our projects typically proceed.
  • Regulatory Compliance Page. See how we maintain regulatory compliance.

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

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

Always Learning

  • 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.

See our Medical Device Design Roadmap

Learn the process

What our customers say

CEO Recommendations

Featured Projects

DeviceLab's Customers