IVD/IVDR Regulatory Compliance Toolkit — IVDR classification guide, performance evaluation plan, scientific validity template, clinical performance protocol, technical documentation checklist, and labeling requirements.
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This toolkit is designed for teams facing these challenges:
Yes, including scientific validity, analytical performance, and clinical performance documentation aligned with IVDR Annex XIII and MDCG guidance.
Yes, the classification guide specifically addresses re-classification under IVDR and identifies where existing IVDD documentation needs to be upgraded.
Download immediately after purchase. All templates are editable Word and Excel files.
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