Regulatory Packages for Startup Companies
We offer cost-saving packages for strategic regulatory activities.
510(K) Predicate Device Package
We recommend this package for developers of medical devices aiming to follow the FDA 510(K) route which identifies the most suitable predicate device for their product.
You provide the product information – we find the best predicate device(s).
- You supply BIOREG with concise information about the product together with details of its mode of action (MoA), intended use and indication for use.
- We will deliver a report to you which will list the possible predicate devices and recommend the “primary” predicate and a “reference” device, if available. The report will also include a substantial equivalence comparison table for the listed products.
- And we will also remind you about the next steps to take!
Regulatory Assessment Package
We recommend this product for start-up companies who wish to identify which regulatory pathway is the most viable for their product.
You provide the product information – we generate a regulatory assessment report.
- You supply BIOREG with concise information about the product and a summary of available preclinical, biocompatibility and clinical data. You should also indicate the market of interest and the preferred regulatory path.
- We will deliver a product specific regulatory affairs assessment report which will include all viable regulatory pathways with product classification. We will also suggest the most feasible regulatory pathway for your product bearing in mind the company’s goals.
- We will discuss the report findings over the phone or via a Skype session.
- And we will also advise you about the next steps to take!