Greenleaf Health was engaged by a global medical device company to assist in conducting due diligence for the potential acquisition of another device company. Greenleaf’s Advisory Services Team evaluated the target company’s FDA compliance history and regulatory status, as well as their promotional and advertising materials, in order to assess the regulatory risk that would be assumed with an acquisition, and specifically, to help the client understand the level of investment that would be required to ensure compliance.

Greenleaf initiated the due diligence process by reviewing the target company’s Medical Device Reporting (MDR) readiness and quality system risks. The diligence also encompassed evaluation of the target company’s quality manual and selected standard operating procedures; registration and listing; product clearances; modifications and letters-to-file; product labeling; vendor oversight; regulatory inspection history, including Form 483s, warning letters, establishment inspection reports, and company submissions to the regulators concerning the inspection; external audits (and quantification of the risk of subsequent audits); internal audits; adequacy of progress of corrective and preventive action (CAPA) plans; and other quality plans and remediation programs.

Greenleaf delivered our findings and conclusions in a written report that detailed the assessment, identified existing and potential quality and compliance challenges that might arise in merging the acquiring and target companies’ quality systems, and outlined a roadmap for the client to consider in advance of acquiring the target company. The Greenleaf team also participated in several report-out calls.

While Greenleaf’s experts provided the FDA regulatory risk assessment for this project, the team also worked with individuals from several other consulting groups to develop the complete due diligence landscape. The diligence was completed within the tight timeline requested by the client and gave them the information and confidence needed to proceed with the acquisition.

Based on the value of Greenleaf’s involvement with this project, the company returned to Greenleaf and retained our Advisory Services Team to assist with a new due diligence project.