Design and Development Planning
The team at Raisin Bioscience can help you create the processes needed to incorporate design controls, design inputs, verification, validation and risk assessments to create a robust design history file for your product.
Regulatory Submission
The US FDA submission can seem overwhelming. The team at Raisin Bioscience have the experience and expertise in 510k, PMA and De Novo submissions. We are your choice, whether you need someone to write the submission or complete all the steps from testing to submission.
Product Development
This is a critical stage to incorporate all the studies and specifications necessary for a successful product submission and launch.
Supplier Network
The team at Raisin Bioscience has worked with various suppliers for IVD manufacturing and we can help you find suppliers that have already been vetted for your raw material and specimen needs.
Clinical Studies
Many people confuse clinical studies with analytical studies (performance studies). Clinical studies refers to studies to show how accurately a test predicts the presence or risk for a given condition. This relates directly to the intended use and indications for use.
The team at Raisin Bioscience can manage the clinical studies from writing protocols, identifying the clinical site, specimen procurement, site visits, biostatistics and study reports.
User Needs
It is critical to understand the needs of anyone who will interface with your device, be it lab personnel, clinicians or patients. The guidelines for IVD testing are changing rapidly. The team at Raisin Bioscience is current on new regulations and guidelines to help you define the “Intended Use” (purpose of your device) and “Indications for Use” (medical conditions that your device is aimed to treat, prevent, diagnose, cure or mitigate)
The Raisin Bioscience team has a network of scientific minds and industry thought leaders and will help you navigate this process before you embark on the regulatory submission.
Medical Writing
Product labeling is an important part of your submission. This requires a clear understanding of the product, regulations and marketing. The team at Raisin Bioscience is well versed in writing IFUs, manuals and creating product labels to ensure that it meets regulatory and marketing needs.