Personal Protective Equipment (PPE): Regulatory Requirements
Personal protective equipment (PPE) is a daily necessity in many occupations, including healthcare, and it is important to understand their…
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EU Regulatory Importer Requirements for Medical Device Software (MDSW)
While the MDCG has worked extensively on building up the library…
Medical Device Risk Management for Device Manufacturers
Like other types of therapeutic products, risk is…
European Authorized Representative Under MDR/IVDR: IGJ Inspection
The medical device industry plays a pivotal role in healthcare, ensuring access to essential devices while upholding stringent regulatory standards.
Post-Market Surveillance (PMS) and Vigilance: US & EU Guide
According to the EU MDR, post-market surveillance (PMS) is the “proactive,…
Common Mistakes When Undergoing MDR Notified Body Agreements
The revised transitional provisions of the MDR allow for the following devices to be placed on…
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…
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