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FDA QMS and ISO 13485 Compliance for Medical Device Software Developers

Companies developing cutting edge software for patient monitoring, digital therapeutics, mental health and other applications may wonder if their software is regulated, and if so, how to comply with FDA and international quality management system standards and regulations. Our team of medtech consultants can answer both questions and put you on the path to compliance, quickly and efficiently. 



Let Our QMS Team Answer These Important Questions …

  • We make software, not products. Do we need a QMS?
  • What’s involved in meeting FDA and ISO 13485 requirements?
  • How do FDA and ISO 13485 overlap? Where do we begin?
  • How long will it take to comply? How much will it cost?

QMS Implementation for Developers of Software as a Medical Device (SaMD)

We get it. You need to stay nimble and you don’t want a Quality Management System (QMS) to slow down the development process. You’d rather wait as long possible to implement a full QMS. Unfortunately, the longer you wait, the more challenging it becomes to pass your certification audit and get regulatory approval. Why? Companies that don’t properly document design history and other critical information from the outset end up scrambling to meet key FDA 21 CFR Part 820 and ISO 13485 requirements. Often, it doesn’t end well. Being proactive about QMS compliance early pays off big time once you are ready to submit for FDA or CE Marking approval.

Do You Outsource Software Development?

You can outsource coding but you can’t outsource compliance. Even if you outsource all software development, FDA considers you the “legal manufacturer”, the same status as a medical device manufacturer making physical products. This means you must have a fully compliant QMS. Keep in mind , a well-designed QMS will actually help you to develop a more effective product the first time and minimize rework in the design phase when updates and patches are released.

An Action Plan for Speeding Your Path to Approval

We know most software startups don’t have the internal resources or expertise to implement a QMS and that’s why we take an iterative approach to QMS compliance. We will interview your management team, conduct a baseline assessment and provide a formal action plan based on your unique situation including a timeline detailing your path forward. You then decide if you want to take the next step toward QMS certification!

We Can Assist With:

  • FDA & EU Regulatory Pathway
  • Design History File (DHF)
  • Device & IVD Classification
  • ISO 27001 Compliance
  • QMS Gap Assessment 
  • IEC 62304 Compliance
  • Document Control
  • FDA & ISO 13485 Training

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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