You want to make sure your Medical Device Software Development solution meets FDA requirements. Our quality assessment processes can help you pass compliance tests with flying colors.
Whether you want to upgrade your quality management system or build your own QMS from scratch, you can count on The RND Group’s expertise. We help clients meet both new and updated regulations, standards, and guidelines for their projects.
A Defined Process
The RND Group essentially offers two types of assessments. The first relates to our instructions and templates for creating your own Medical Device Software Development project documents. Our team routinely helps clients get their QMS in place before they even start development. We catch errors the first time, so you can make the necessary adjustments before moving forward.
When clients already have completed Medical Device Software Development documents, we can provide detailed project/product document assessments. Submitting your standard operating procedures and process documents to our QSA team first helps you avoid delays down the line.
You can work with us from the start or come to us with your existing Medical Device Software Development documents. Either way, we’ll ensure that your submission will be accepted by the FDA or any other regulatory body. We produce a formal report for each of our client’s projects. Comparing these findings against the compliancy requirements then allows us to create a recommended path to get to market.
Build Your Own Software QMS
Some clients come to us with a quality management system already in place, but they have nothing related to software. This is where we shine. Delivering Medical Device Software Development is at the core of what we do, and we’re committed to driving our clients toward compliancy.
The RND Group can complete your QMS for the software sections. We can even review your software code to analyze specific problems, as needed. Our proven method for establishing procedures and templates for clients to use helps ensure that their software is compliant to any and all of the applicable regulations, standards, and guidelines.