Potential areas of concern include ‘letters to file’ that should have required a regulatory submission or involvement of a regulatory body. Product issues in the field that were not handled properly as complaints, such as thorough investigations, impact/ risk assessments, corrections/ removals, and reporting to regulatory authorities. The lack of robust product technical files and design history file documentation is a common issue. Without solid supporting design documentation, it is extremely challenging to justify design changes, such as changes in materials, manufacturing processes, or the supplier base. If the acquisition of the company is being driven by a specific product portfolio, you should be prepared to do a deep dive into the technical files or 510K or PMA, the clinical evaluation, any critical contractors or suppliers, the type of complaints received, any CAPA’s that have opened, and issues that have been escalated.
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