Developing IEC 62304 Compliant Software Is Not Trivial
IEC 62304 compliance means your medical device software development lifecycle, risk management, and documentation meet the international standard’s requirements, in step with ISO 13485 and ISO 14971. Meeting all three is not simple, and adding regulations like GDPR into the mix can make the requirements feel overwhelming without expert guidance.
IEC 62304 is the standard most medical device software must meet, and its importance goes far beyond regulatory compliant manufacturing and development. Here is where to start.
First, ask yourself these specific questions:
- Is your software meeting its regulatory requirements?
- Does your software development life cycle employ industry best practices?
- 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. For more than 25 years, our software has supported medical device companies through FDA submissions, and it has never been the reason a submission stalled.
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 62304 and FDA Cybersecurity Guidance Standards.
Once The RND Group completes the assessment, customers receive a comprehensive report that identifies areas of non-compliance, along with recommendations and a roadmap toward compliance to support a stronger 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