The medical device field is expanding and evolving as are the regulations that guide development. Products in a medical manufacturer’s portfolio must deliver value and meet clinical needs.

Over 25 years delivering innovative solutions

With a sole focus on designing and developing classified medical devices, we have the regulatory registrations and certifications, in-house knowledge, global suppliers and vertically integrated process in place to bring your medical device from concept to launch. As a single source solution for your medical device development we reduce program risk, cut development costs and meet your go-to-market timeline.

We bring intuitive use to complex systems & environments

Our medical device programs vary in scale and scope. We excel at solving design and development challenges from robotics to fluid management systems, delivering sophisticated technologies that are safe and easy to use despite their complexity. FDA Registered and ISO 13485:2012 Certified, our experience and expertise in navigating guidelines allows us to focus on human-centered design throughout the development process.

Product Categories in Which We Work

  • Endoscopic devices
  • Laparoscopic tools
  • NOTES devices
  • Access devices
  • Emergency care systems
  • Infusion systems
  • Clinical diagnostic devices
  • Respiratory therapy
  • Drug delivery systems
  • Electrosurgical devices
  • Urologic ablation
  • Nerve stimulation
  • Blood management devices
  • Tissue securement devices
  • Ultrasound devices
  • Physician Assist devices
  • Dental products
  • Oral appliances
  • In-home rapid diagnostics
  • Women’s health products
  • Remote monitoring
  • Diabetes care
  • First aid & pain management


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