adminMTE_04792023-03-29T14:46:55+00:00January 28th, 2022|Categories: Uncategorized|Tags: Conformity Assessment, EU IVDR, Invitro Diagnostics, MedTech, Post Market Surveillance, Regulatory Affairs|
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 collection, generation and documentation of supporting data for an IVD may be conducted prior to the placing [...]
adminMTE_04792023-04-21T10:48:30+00:00January 29th, 2021|Categories: Regulatory, USA|Tags: ASCA, CDRH, Conformity Assessment, FDA, USA|
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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