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The new In Vitro Diagnostic Regulations (EU-IVDR) brings a number of significant changes, putting pressure on all the In Vitro Devices companies to closely examine the regulation, assess the impact it will have on their own organization, and implement compliant processes and procedures accordingly. With limited time until 2022, it is critical to swiftly go around devising new regulatory strategies in order to move forward efficiently and in time.
HCL is the one-stop answer to all your IVDR needs - assessment, prioritization, transformation.