FDA Readiness Assessment

Submissions for FDA-regulated medical devices can be a costly challenge, but planning for it shouldn’t have to be.

Get Your Device FDA Approved on Submission with our Readiness Assessment

The FDA Readiness Assessment is a packaged service designed to provide a thorough and independent assessment of a company’s readiness to submit their FDA-regulated medical device software product for approval.

The assessment evaluates a company’s quality system and design history documentation against IEC 62304 compliance and the FDA Cybersecurity Guidance standards.

The FDA Readiness Assessment is Ideal for Companies:

  • Developing their first medical device that includes software.

  • Updating a released medical device to operate in a networked environment.

  • Transitioning from a RUO (research use only) device to a medical device.

  • With management or investors seeking an independent opinion on another company’s readiness for submission.

  • With a quality management system that does not fully address software as a medical device (SaMD).

Upon completion, customers receive a detailed report identifying areas of non-compliance and specific recommendations, as well as a roadmap for ensuring compliance for FDA regulated medical device software products.

The RND Group is Experienced In:

  • CLIA waived devices

  • Class 1 medical devices

  • Class 2 medical devices

  • IEC 62304

  • ISO 13485

  • FDA 21 CFR Part 820

Your Project Deserves a Specialist

Is your medical device meeting FDA regulation requirements?
The RND Group can help get your project ready.

Our experience boasts
approval for 75+ FDA-regulated medical devices.  

The RND Group has a track record that is unmatched in the industry when it comes to knowledge and success in delivering FDA-regulated medical device software development products.