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We have particular expertise in these 4 branches of medical device design.
Digital Health, Wireless & Wearables
Connecting patients to care givers using wearable devices, sensors, smart phones/tablets, apps, and cloud technologies is rapidly changing modern healthcare.
Lasers & LED Technologies
Leveraging compact lasers and LED sources to enable safe and novel diagnostics and therapeutic devices. Medical devices that use precisely focused light sources to treat or remove tissues.
Complex electro-mechanical IVD diagnostic systems for laboratory, Point-of-Care, and hospital. Including system controls, measurements, fluidics, optics, Software, and data management.
Patient Monitors / Imaging Systems
Reliable, patient-friendly monitoring of vital signs: Body Temperature, Pulse Rate, Respiration Rate, and Blood Pressure. Class I, II and III diagnostics and therapeutics systems for hospital, home, and office use.
Why Choose Devicelab?Watch the Video
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.
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.
- ISO 13485 Certified (Medical Device Design and Development).
- 400+ engagements.
- Gold medal award from MDEA (Medical Design Excellence Awards).
- 20 years of operations.
- 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.
- 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 RoadmapLearn the process
What our customers say
- “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.“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
- “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.“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
- “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“The entire team at DeviceLab quickly understood our objective, and were proactive in making suggestions “
Michael Favish ; CEO | Guardion Health Sciences
- “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.“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.
- “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“DeviceLab was exceptionally resourceful, always ready to have creative solutions for any problem that we encountered.”
Brigitte Phan ; Patent Agent | Allergan