Clinical Evaluation without Clinical Data in the EU
Application of EU MDR Article 61(10) When Clinical Data is Conside...
Implications of AI on Medical Device Technology and Certification
Currently, AI refers to the ability of machines to perform cogniti...
Pharma/Biotech – USA, Europe and Asia Regulatory Updates Roundup – Sept 2024
USA
FDA Approves Drug with New Mechanism of Action for Treatment o...
Medical Devices – USA, Europe and Asia Regulatory Updates Roundup – Sept 2024
USA Air Powered Dental Handpieces and Air Motors – Performance Cri...
Software IN versus AS a Medical Device
The healthcare industry has always relied on new technology to dri...
Medical Device Label Designing Important Considerations
Medical Device Labeling – an essential aspect of the Medical...