Swissmedic Guidance on Incident Reporting: Specific Aspects
The new article describes in detail certain specific aspects related to the incident reporting requirements introduced in Switzerland.
The new article describes in detail certain specific aspects related to the incident reporting requirements introduced in Switzerland.
The article highlights the key points related to the regulatory requirements in the sphere of incident reporting in the context of healthcare products allowed for marketing and use in Switzerland.
The new article elaborates on the specifics of the regulatory approach medical device software products are subject to.
The article provides an overview of the trend report template issued by the Swiss regulating authority.
The new article highlights aspects related to electronic submissions and specific types of products. Table of Contents The Swiss regulatory authority in the sphere of healthcare products (Swissmedic) has published a guidance document dedicated to the regulatory...
The guidance addresses aspects related to the safety measures to be developed and introduced by the parties responsible for performance trials in order to ensure the safety of study participants while maintaining the accuracy and reliability of the study results....