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HCL Technologies

IVDR Challenges and Approach for Implementation

IVDR Challenges and Approach for Implementation

This white paper focuses on the impact of IVDR on the IVD industry and suggests an approach to implement the new rules. It involves a substantial amount of time and additional resources, needless to say, a new strategy, and a complete set of new documentation to implement IVDR. HCL’s team has been meticulously working on the new rules and has developed checklists to quickly assess a manufacturer’s compliance and re-usable templates to fulfil them.

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