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…
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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…
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…
Integrating Swiss MedDO and IvDO into your QMS
Despite the Swiss Medical Devices Ordinance 812.213 (MedDO) having entered into force on May 25, 2021, and In Vitro…
IVD Incident Reporting: Regulatory Standards for Manufacturers
In the complex world of medical device and IVD manufacturing, adherence…
Navigating the Current US FDA Medical Device Classification
For manufacturers looking to enter the US medical device market for the first time, the US FDA approach to…
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