Welcome to Conatus Consulting, LLC
– – In Vitro Diagnostics (IVD) Regulatory Specialists
Founded in 2009, Conatus Consulting focuses on providing turnkey comprehensive regulatory advice, guidance, and action on IVD products and services.
Our clients utilize our services to assist in IVD products including: Laboratory Developed Tests (CLIA/CAP), FDA 510(k) submissions for IVD kits and systems, and FDA Premarket Applications (PMA) for Class III products including Companion Diagnostics.
We pride ourselves in being a part of the regulatory and Product Development team. This allows us to help clients with all required elements of a compliant regulatory process including:
Design History File (DHF), Quality Management Systems (QMS)and Quality System Requirements (QSR).
How do we start? Usually our clients start with an audit or inspection of their existing Quality Management System, a “Gap Analysis” to help determine where they stand in the implementation of this critical element for all manufacturers of IVD products.
Second, we provide strategic Guidance on how to remediate any gaps identified in our initial review and help our clients prioritize next steps towards the eventual goal of submitting an application to FDA for marketing clearance or approval.
As an integrated part of the Product Development team, we guide our clients in the Design Control process as required by FDA QSR regulations. This process also benefits the Company directly by insuring the final product meets or exceeds standards resulting in a product that is robust, reproducible, accurate, and sensitive in generating the best and expected results.
Please contact us if you need any assistance with your IVD product, whether you are at the initial Concept Phase or heading towards full Commercialization. We can help you and set the stage for success!
Phone: (919) 201-7476