IVDD to IVDR Transition
LINK Medical can support you with the full IVDD to IVDR Transition process. We deliver a gap analysis, audit your ISO 13485 QMS, write the Performance Evaluation Plan (PEP) including a state-of-the-art literature search, analytical validation, and we design, submit and execute the Clinical Performance Study (CPS). We deliver a Performance Evaluation Report (PER) for IVDR CE-certification.