The word “literature” is mentioned approximately 30 times in MDR 2.7/1 rev 4. As a fundamental component of CERs, literature reviews are used to:
• Identify and evaluate safety and performance data;
• Establish state of the art; and,
• Monitor risks and reconfirm device risk profile.
What are the notified bodies looking for? How can you ensure your process will deliver fully compliant literature reviews? And, since literature reviews require periodic updates, how can you produce and maintain your reviews sustainably? This talk will highlight the importance of automation in the literature review process to ensure compliance with the new regulations.