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Reviewing MDR Requirements, when a clinical evaluation of software is required and MDCG 2020-1.
When a clinical evaluation of software is required.
MDCG 2020-1 clinical evaluation of MDSW.
The clinical Evaluation process for MDSW.
Considerations for clinical investigations.
BSI interpretation of MDCG 2020-1 and how clinical evaluation should be applied to this group of devices.
Head of Clinical Compliance, BSI.
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