An FDA submission can be a costly challenge, but planning for it shouldn’t have to be.
The FDA Readiness Assessment is a packaged service offering designed to provide a thorough and independent assessment of a company’s readiness to submit their Medical Device Software Development product to the FDA for approval. The assessment evaluates a company’s quality system and design history documentation against IEC 62304 and the FDA Cybersecurity Guidance standards.
Upon completion of the assessment, customers receive a detailed report identifying areas of non-compliance and specific recommendations and a roadmap for ensuring compliance of their medical device software.
This assessment is ideal for the following types of companies:
- 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 another company’s readiness for FDA submission
The RND Group has a track record that is unmatched in the industry when it comes to knowledge and success in delivering Medical Device Software Development products. We have participated in the successful FDA approval and launch of more than 50 products.