Due diligence activities should cover all applicable regulatory requirements of the firm based on the company’s role and the type of medical devices on the market given the geographical region in which they are marketed. Diligence should include a review of the status of registrations, listings, licenses, and planned or pending submissions requiring regulatory agency involvement or approval. A review of product labeling and advertising to ensure all claims are consistent for the approved intended use to mitigate potential risks of misbranding and enforcement actions.
Assessment activities should include a review of established quality system procedures, staff training, design and production histories, critical suppliers, device and process validations, technical files, submissions, and status of certifications. A review of audits, disciplinary measures and corrective action plans provide insight into the effectiveness of the quality management system and commitment of the executive management team.
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