Response, Remediation & Due Diligence

Responding to FDA Findings & Objectionable Conditions

Responses to FDA Form 483, Untitled Letters and Warning Letters have significant implications in what steps the Agency takes next. Let us help you deliver a timely, accurate and complete response that ensures corrections, root causes and corrective actions are identified.

Remediation of FDA Findings & Objectionable Conditions

Execution on the commitments made to the FDA must be completed in a thorough and comprehensive manner. The actions must be completed and documented using the established or revised Quality Management System processes. Texas Medical Device Consultants will help you implement, complete, document and present your remediation efforts to avoid business interruptions, last minute scrambles and repeat observations.

Due Diligence – Acquisitions, Mergers, & Business Development

The team at Texas Medical Device Consultants has experience working with companies large and small during changes in ownership and structure of the company. Intelligence on the state of the Quality and Regulatory systems and documentation is critical to accurately assessing the risk profile and valuation metrics. Weak or incomplete information on product development or change documentation can lead to significant delays in product transfer and expansion – or worse. Texas Medical Device Consultants provides independent, thorough and objective feedback regarding the companies or products under consideration.