Medical Device Adverse Event Reporting Regulations: EU vs. US FDA
Regulatory authorities in both Europe and the United States requir...
MHRA Final Rules for Post-Market Surveillance
Medicines and Healthcare Products Regulatory Agency (MHRA) finaliz...
The Role of Human Factors in Medical Device Usability Testing
Medical devices play a critical role in modern healthcare, saving ...
Mastering New Labelling Regulations: Essential Guide to Medical Device Manufacturers
In the ever-evolving medical device industry, regulatory complianc...
IVDR New Guidance on Safety Reporting in Performance Studies
The Medical Device Coordination Group (MDCG) has recently publishe...
Sterilization Regulatory Requirements and Supporting Standards
Sterilization of medical devices is a critical process integral to...