MDCG 2022-2 Guidance on general principles of clinical evidence for IVDs

2022-09-30T15:53:14+00:00January 28th, 2022|Categories: Regulatory|Tags: , , , , , |

MDCG 2022-2 Guidance on general principles of clinical evidence for in Vitro Diagnostic medical devices (IVDs) New #MDCG Guidance on general principles for #clinicalevidence and the continuous process of performance evaluation for #IVDs has been published The guidance describes the approach by which [...]

US: CDRH plans full launch of ASCA pilot program in 2021

2021-01-29T10:01:36+00:00January 29th, 2021|Categories: Regulatory, USA|Tags: , , , , |

The US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH) annouced the full launch of a pilot conformity assessment program in 2021. Contact Meditrial to know about our strategic assessments of regulatory requirements to address business [...]

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