Prevail has developed specific analytics and tools for this market and has the software engineers and clinical experts to address any new requirements that develop.
Prevail has had significant experience in Medical Tech having worked on products that received FDA approval in the Medical Device space and worked on many other medical device or diagnostic products throughout the years. It knows the clinical nuances and the shifting regulatory requirements as the FDA and the CDRH tries to keep up with the innovation in this space. Prevail has developed specific analytics and tools for this market and has the software engineers and clinical experts to address any new requirements that develop.
While Prevail typically works with Class II or Class III products targeting a PMA approval and requiring pivotal IDE studies in the medical device or diagnostic areas, it can also scale down its technologies to also be useful for pilot studies and products going for a 510(k) or de novo 510(k) approval as well. Particularly on diagnostics, we typically work with IVD diagnostics and have also worked with pharmacogenomics diagnostics but have the flexibility to deal with any project or program requiring collection, integration, reconciliation and/or analytics of data across a large body of data.
Take a look at some case studies or speak with a data scientist to see if real-time data is right for your project.