IVDR is more than MDR minus clinical requirements. The truth is, evolving audit requirements and MDCG interpretations are the root problem, but auditing bodies and consultants don’t want to talk about it.  Continuous improvement to reach IVDR certification can be a marathon, but a process to reach certification can help support the transition.  With QMS Velocity, you are given solutions, proven solutions that you can integrate with your existing QMS and organization.

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.