According to the post-market surveillance and vigilance requirements written down in MDR Article 83 and FDA CFR 21 820, there is a need to systematically and actively gather information from post-market experience and establish a comprehensive post-market surveillance system. In order to meet these requirements, LITERO will prepare and continuously update your post-market surveillance plan and support you by regularly and continuously providing relevant information from:

• Scientific literature databases (e.g., Medline, Embase)
• Authority databases (e.g. FDA, BfArM, EUDAMED)
• Websites
• Social Media
• Others

As information gathered through post-market surveillance should be used to update any relevant part of the technical documentation, in particular Periodic Safety Update Report (PSUR) and Clinical Evaluation (CER), we will check your documentation and support you in your process development.