BioStat Solutions, Inc is experienced in supporting medical device companies seeking FDA approval. We offer comprehensive and cost-effective solutions to the delicate and dynamic regulatory process.

Whether you are developing an in-vitro diagnostic device or need assistance in a reader study, BSSI offers the insight and analytical services necessary to reduce time and cost, and ultimately increase your chance of approval.

Our experts can assist you from the planning stages to regulatory submission to post-marketing strategies, with experience in the following:

• Designing, analyzing and interpreting medical device trials
• Preparing regulatory documentation, including:
  • Clinical study protocols
  • Pre-market notification 510(k) submission
  • Investigational device exemption (IDE)
  • Pre-market approval (PMA)
• Representation in the FDA regulatory process

We have expertise in a wide-range of biostatistics methods.

For more information on how our statistical analyses on medical device trials are conducted in accordance with FDA guidelines: Regulatory Compliance.

Contact us for more information about these and other capabilities.