SMI Solutions – Regulatory Consulting

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 an 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’s speedy path to market.

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

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