Medical Device

At Boundary Systems we work to help you develop, manufacture and commercialize products that help people live longer, healthier and more enjoyable lives.    With a specialty in complex CAD tools, Boundary Systems has the experience and technology to assist medical device companies to implement the PLM, CAD, and requirements management technology necessary to develop quality products, get to market faster, control costs, and meet FDA requirements.

The medical device industry is approaching a tipping point where the increasing likelihood of a quality event, the rising costs of such events, and the public nature of quality performance will force companies to focus on quality and reliability throughout product design, manufacturing, and marketing.   In order to do that, companies should look to implement design systems that are broad in capability and flexible to adapt to the ever changing market and regulatory demands.    With Boundary Systems and their expertise in PTC software products for medical device, we are able to help companies quickly implement and utilize these modern solutions including

  • Device Master Record
  • Design History Records
  • Design History Files
  • 21 CFR Part 820
  • 21 CFR Part 11