Update on Swissmedic FSCA Report and PRRC Change
Changes to Swissmedic FSCA Report V2.3 Swissmedic has recently updated the Foreign Serious Incident Report (FSCA) template to version 2.3.
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Common Mistakes When Undergoing MDR Notified Body Agreements
The revised transitional provisions of the MDR allow for the following devices to be placed on…
Australia Prostheses List and Implications for Medical Device Manufacturers
Following several years of industry complaints regarding the process for obtaining private health insurance reimbursement authorization for devices and…
EU MDR Compliance Deadline for Legacy Devices is Approaching
By 26 May 2024, manufacturers must have an MDR compliant Quality Management System in place and have lodged an application…
FDA eSTAR Program Simplifying Medical Device Regulatory Submissions
Since its initial pilot and coming into force for non-exempt 510(k) submissions in October 2023, the FDA eSTAR Program…
3 CE Marking Regulatory Challenges and Proven Solutions
Embarking on the process of introducing a new medical device or in vitro diagnostic (IVD) product to the market requires…
MDR Transition: Greatest Impacts on Medical Device Manufacturers
Amidst the ongoing evolution of the medical device industry, the MDR transition has become a pivotal focus. The Medical…
eIFU Requirements Under the MDR
The Medical Device Regulation (MDR) introduces a comprehensive framework that integrates multiple electronic instructions for use (eIFU) requirements, further supplemented…
FDA Issues Final Guidance on Sterilization of Medical Devices
The FDA has issued a final guidance on the sterilization of devices labeled as sterile. The guidance updates and clarifies…
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