Are you introducing a new medical device to market? Having trouble with ISO certification? We can help.

Welcome to SMI Solutions

SMI-Solutions provides global medical device regulatory and quality consulting. We can help you access the fastest growing device markets worldwide. Our services include:

  • Medical device regulatory strategy
  • Medical device registration and approval
  • Medical Device Establishment licence registration
  • Labelling compliance
  • Quality systems compliance
  • Medical device reporting requirements
  • Recall navigation
  • Post market surveillance
  • Canadian representation

Let experience clear your path to market.

Product development, product launch and marketing of medical devices are highly regulated processes. Navigating through regulations can be challenging. They vary from region to region and can be unclear and complex. Our experienced regulatory professionals can navigate through these regulations helping you capture and grow your market share without regulatory hold ups.


SMI-Solutions is committed to maintaining Southmedic’s reputable high level of customer service. Your product will get personalized attention from experienced regulatory and quality professionals. We will work with you to develop expeditious, effective and cost-conscious regulatory strategy. We are committed to getting it right the first time by anticipating regulator expectations to ensure your product a speedy path to market.