Business-Balanced IVDR Planning and Execution

The 26 May 2022 EU IVDR date of application is not going to change, and even with the extended transition period for some device classes, manufacturers are running out of time.

Expert Leadership

With BSI Technical Team Manager and first IVDR internal clinician Carlos Galamba on board, the IVD team at RQM+ is here to help. With industry-leading project management, regulatory leadership, and skilled tactical implementation, we provide support that enables you to complete every aspect of the work on time.

Comprehensive Solutions

We start with an IVDR impact assessment to set a framework and ensure your submission goes as smoothly as possible. This is a high-level examination of your products against IVDR requirements that could have a significant impact on your business, and includes:

  • Notified body engagement
  • Intended purpose and classification assessment
  • QMS impact
  • Technical documentation expectations (including risk management)
  • Performance evaluation reports (PERs)
  • Economic operators
  • Labeling (including UDI and translations)
  • Post-market surveillance

Based on the assessment, we build a foundation for alignment between teams, resources, and regulatory intelligence. Deep-dive gap assessments tell us where to focus resources and allow us to develop and finalize customized program and remediation plans based on the specific needs of your business. After we create the roadmap, we help you execute the plan to completion. 

No matter where you are in the process or what types of IVDs you manufacture, our expert team is here for you. From strategy to implementation, we deliver business-balanced solutions that align with your organizational goals.  

Let’s chat about what the RQM+ IVD team can do for you. Just fill out the form, and we’ll be in touch.


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