For FDA-regulated products, cleared claims control what you can say about your product: what it does and how it can be used. You may have an amazing piece of technology, but an oversight in establishing claims can result in providers being unable to be reimbursed for its use.

Kadath Group will work with you to identify key claims for reimbursement and establish differentiation in the marketplace. Best practice is to start during solution development, so that product requirements, clinical trials, and FDA submission are aligned to produce the claims necessary for success.

We add value to your development, clinical, and regulatory teams by bringing a holistic view to their efforts. Our consultants understand each team’s perspective and facilitate communication between stakeholders to produce strong collaborative efforts.

Our founder has multiple successful 510k clearances to his credit. He knows well-planned clinical trials and claims are the gift that keeps on giving. A good clinical trial supports the regulatory filing and also provides the data for peer-reviewed publications. Strong claims empower your sales people to deliver a clear compelling message to customers. Kadath Group is ready to enable your company to get the most out of its efforts.