TGA UDI System: What Manufacturers Must Know for Compliance
The Therapeutic Goods Administration (TGA) Unique Device Identification (UDI) system has been in development for several years with several…
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QSR vs. QMSR: FDA’s New Quality System Requirements
On February 2, 2024, US FDA published the final rule harmonizing its quality system requirements to…
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…
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…
EU Regulatory Importer: Legal Liabilities & Considerations
Manufacturers of Medical Devices and In Vitro Diagnostics (IVDs) located outside the European Union (EU) are required to appoint an…
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