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Apsis Consulting Group is a boutique firm providing high-value quality and regulatory services for small medical device companies and start-ups looking to bring their products to market, fix quality issues or prepare for regulatory scrutiny.

Regulatory Submissions

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We can help develop your regulatory strategy for Class I, II, or III Medical Devices and IVDs. We can also partner with your team to lead meetings with FDA to discuss controversial topics such as device risk, device down-classification (de novo), clinical study strategy, and human factors studies.

  • Regulatory Strategies

  • 510(k) Notifications

  • De Novo Classification Requests

  • Gap Assesments for Submissions

  • FDA Small Business Qualification Applications

  • Investigational Device Exemptions (IDEs)

  • Humanitarian Device Exemption (HDE) Applications

  • FDA Pre-Submission Meeting Requests (Q-Submissions)

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US Agent Services

Looking to sell your medical devices in the USA?

 

Our U.S. Agent services represent foreign manufacturers and key suppliers, streamlining communication with the FDA, assisting in inspection planning, and addressing FDA inquiries.

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