Australia
The article highlights the critical points related to the regulatory requirements for quality management system audits and certification.
FDA
The article highlights the key points associated with factors to be considered when determining the eligibility of a medical device type for a third-party review program under the 510(k) framework.
FDA
The article highlights the aspects related to the key considerations for methodologies used in the context of the collection and analysis of real-world evidence.
FDA
The new article highlights the aspects of the documentation the authority expects to be submitted for review.
EU
The article provides an overview of the regulatory approach to be applied with respect to clinical investigations involving medical devices in the context of exemptions.
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