Auteur: acs

IVDR (EU-2017/746) & corrigenda

Regulation (EU) 2017/746 of April 5, 2017 1st Corrigendum (May 3, 2019) 2nd Corrigendum (December 27, 2019) EU’s IVDR (and MDR) implementing measures rolling plan

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CIOMS’ free e-learning on the International Ethical Guidelines for Health-related Research Involving Humans

The Council for International Organizations of Medical Sciences issued the course with the main aim to learn to navigate these CIOMS guidelines. The course includes example case studies and a certificate at the end. The purpose is not to replace a GCP-certificate but to assist the reader in their understanding of how to apply these […]

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IMDRF guidances on clinical evaluation

On Clinical Investigation On Clinical Evaluation On Clinical Evidence On Adverse Event reporting

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ISO 20916:2019 – IVDs – Clinical performance studies using specimens from human subjects

ISO 20916:2019

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