DeviceLab is a medical device design and development company. DeviceLab is ISO 13485 certified and has been in business for over 20 years. Our track record includes over 100 successful significant projects and many smaller ones over 400 in total. This track record emphasizes our understanding of stringent FDA requirements and ISO standards. We design devices for use at home, Point of Care (POC) or hospital environment. We have won an MDEA Gold Award and finalist considerations. We work with early-stage to Fortune 100 companies. Check our Recommendations page to see who has benefited from working with DeviceLab and our Portfolio page for more about the projects we’ve done. Our Media page has timely content about what’s up at DeviceLab and in the industry.


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 Choose Devicelab?

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

  • DeviceLab is ISO 13485 certified for Medical Device Design and Development. Our client’s project will likely cruise through lab testing and FDA since we take the time to set up project requirements thoroughly.
  • Our track record includes over 100 successful major projects and many smaller ones.
  • Our design has won a gold medal award from Medical Design Excellence Awards, MDEA. We keep up with the latest design trends to create outstanding designs for our clients.
  • We have been in business for over 20 years. We’ve seen many different ways to handle a design/feature.  This experience allows our team to provide many innovative options for our clients.
  • DeviceLab has a well-rounded team of designers and engineers who keep current with the latest medical technologies and design tools, so our clients will get the best technical solutions.
  • Because of our experience, we know how to move medical projects quickly through the phases of development. We have done it so many times successfully.
  • We have design controls over many projects and continually adapt to changes in the regulatory landscape. Regulatory compliance is in our DNA.
  • We’re adaptable to your needs, from quick design studies to soup-to-nuts projects.

The Process page describes how we work and gives some examples of how projects typically proceed. The Regulatory Compliance page provides details about how we maintain regulatory compliance and assure that your product does too.

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