Serbia
The article describes in detail the approach to be applied when requesting changes to the existing medical device registration.
FDA
The new article highlights the aspects related to the applicability scope, and also provides definitions of the key terms and concepts.
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.
