EU
The new article elaborates further on the aspects related to risk management in the context of medical devices to be used in the course of clinical investigations.
EU
The new article clarifies the aspects related to the pre-clinical evaluation the device should undergo before it will be allowed for use in patients.
EU
The new article describes in detail the approach to be applied with respect to labeling for medical devices undergoing clinical evaluation.
Bahrain
The article highlights the key points related to the regulatory framework for implant cards as set forth under the current legislation.
EU
The new article describes in detail the second section of the document addressing mostly the matters related to the risks associated with a medical device and information to be provided in this respect.
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