Are You IEC 63204 Compliant?

Developing IEC 62304 compliant software isn’t trivial. With this, you must develop software that supports its intended use, while also complying with ISO 13485, ISO 14971, and IEC 62304 international standards. Then, if you include GDPR in the mix, you can easily get lost and overwhelmed – unless you leave it up to an expert. IEC 62304 is the gold standard for medical device software, but its importance goes far beyond ensuring regulatory compliant manufacturing and software development. Let’s start from the beginning.

First, ask yourself these specific questions:

  1. Is your software meeting its regulatory requirements?
  2. Does your software development life cycle employ industry best practices?
  3. Will your design history file (DHF) contents be correct and of the quality needed for FDA submission?

If you answered, “I don’t know,” to any of these questions, seek an expert. When medical device companies develop their breakthrough technologies, they need cutting-edge software that ensures safe, secure and FDA compliant operations of their systems. Any software included in a medical device should be IEC 62304 compliant. This is where The RND Group comes in. We are a team of people who excel in our craft, blending skill with a strong passion to build software to meet exacting standards. We’ve successfully helped over 50 medical device companies through the FDA submission process and receive FDA approval.

Your Product Deserves a Specialist

Assessments are powerful tools for your business that can identify the current state of what is being assessed and identify areas of improvement. Assessments can be performed on many aspects of a software project, ranging from measuring a project’s success to evaluating the quality of a specific project deliverable. RND Group offers an FDA Readiness assessment service.

The FDA Readiness Assessment is designed to provide an in-depth and independent evaluation of your company’s preparedness to submit their medical device to the FDA for approval. This assessment compares a company’s quality management system SOPs and work instructions, and design history file documentation to IEC 63204 and FDA Cybersecurity Guidance Standards.

Once the assessment is completed by The RND Group, customers will receive a comprehensive report that identifies areas of non-compliance with recommendations and a roadmap for ensuring compliance for a successful FDA submission.

Does Your Company Fit Into These Categories?

  • Developing their first medical device that includes software
  • Transitioning from an RUO (research use only) device to a medical device
  • Have a quality management system that does not fully address software as part of a medical device or software as a medical device (SaMD)
  • Updating a released medical device to operate in a networked environment
  • Management or investors seeking an independent opinion on their own company or on another company’s readiness for FDA submission

If you answered, yes to any of the above descriptions, then it’s time to talk. Click here to find out more about our FDA Readiness Assessment or email us to find out more! We would love to be a solution for your company!

Authored by: Ali Kissinger, The RND Group, Inc.

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