EUDAMED is similar to the FDA GUDID system and requires manufacturer and importers to register their companies, identify points of contact, and identify product families. Future modules will come online to consolidate and manage vigilance information and other post market surveillance information. This module provides a step by step approach supported with procedure solutions to provide a clear pathway to registration and ongoing compliance.

Simply adding requirements for compliance leads to bureaucracy and requires more resources.  What that means is that you have higher overhead and potentially never achieve your budget or gross margin targets. Worse still, when you remove the resources, you get more issues because of the new procedures and there is more visibility to issues. Every time you add bureaucracy and remove resources, you repeat this cycle increasing your compliance liability.

Adding requirements without efficient tools and processes is like adding weight by eating empty calories and then trying to go on a diet.  The flowcharts and procedures have been developed to provide a roadmap to success and is several iterations and evolutions from starting with gap assessments.