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FDA SaMD Classification and Regulatory Pathways for Medical Device Software

Startups developing standalone digital therapeutics, patient monitoring, mental health, and AI-powered software often wonder if their emerging technology will need to comply with FDA regulations. We will help you definitively answer the question of whether your software is considered a regulated medical device.



Let Our Team Answer These Key Questions for You…

  • Do you need to comply with FDA regulations?
  • If so, which FDA regulations and when?
  • What is required to get FDA 510(k) clearance?
  • How much will it cost and how long will it take?

Deep SaMD Expertise

Oriel STAT A MATRIX software consultants have worked for and with many US and European software developers designing cutting-edge medical software. We understand what makes software a regulated medical device versus a general wellness product, or when it’s not regulated at all. Understanding your regulatory obligations early on will have a profound impact on your company by establishing a foundation for long-term success, and we can guide you through every step of the process.

We will review your software’s…

  • Intended use (claims)
  • Indications for use (conditions for use)
  • User instructions
  • Technological characteristics and potential predicates

We Will Provide a Detailed FDA SaMD Regulatory Roadmap

If we determine that your software is regulated by FDA and considered “software as a medical device,” we will clearly define what will be required to obtain 510(k) clearance from the FDA, assuming your SaMD is considered a Class 2 medical device. We will also tell you which sections of the FDA Quality System Regulation (21 CFR Part 820) apply to your device type, and can work with you to help you achieve compliance quickly.

  • Regulatory Strategy
  • Device Classification
  • 510(k) Submissions
  • QSR Implementation
  • FDA Design Controls
  • Cybersecurity
  • Software V&V
  • FDA Training

If we determine that your software is not considered a medical device, you may celebrate that determination. But keep in mind that being a regulated medical device affords you certain competitive advantages! Ask us why.

We’re Ready to Help

Oriel STAT A MATRIX specializes in helping life sciences companies comply with US and EU regulations. Learn how we can help determine if your software is considered a medical device and outline the road ahead to gaining FDA approval.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

Get answers right now. Call
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US OfficeWashington DC


EU OfficeCork, Ireland

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+353 21 212 8530

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