2019 IMDRF Guidance Changes Related to Clinical Evidence, Evaluation, and Investigations
- Oriel STAT A MATRIX
- 0
- on Apr 15, 2020
Since the release of the European Medical Device Regulation and MEDDEV 2.7/1 Rev 4, medical device regulatory professionals are craving clarity on issues related to clinical data that supports new global submissions and ongoing regulatory compliance. Late in 2019, the International Medical Device Regulators Forum (IMDRF) issued three updated guidance documents that clear up confusion […]
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