HSA Draft Guidance on Clinical Evaluation: Overview
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare products.
The new article addresses specific aspects regarding the Essential Principles medical devices should comply with to be allowed for marketing and use in Singapore. In particular, the article describes in detail the general requirements to be followed, and also the...
The new article describes in detail the approach to be applied when analyzing the data deriving from clinical investigations. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of...
The new article describes in detail different types of data related to clinical evaluation. In particular, the present article addresses the matters related to the data generated through clinical experience, and the data from clinical investigations. ...
The new article describes in detail the aspects related to data sources in the context of clinical evaluation of medical devices. In particular, the document provides an overview of a literature review as a way to collect the data before commencing a study. ...