Steps to Implement ISO 13485 for New Medical Device Vendors
What is ISO 13485?ISO 13485, is specific to the medical device in...
Clinical Evaluation without Clinical Data in the EU
Application of EU MDR Article 61(10) When Clinical Data is Consid...
Software IN versus AS a Medical Device
The healthcare industry has always relied on new technology to dr...
Medical Device Label Designing Important Considerations
Medical Device Labeling – an essential aspect of the Medica...
IMDRF Submission Format for Medical Device
The International Medical Device Regulators Forum (IMDRF) does no...
Usability Testing in Medical Devices: A Comprehensive Guide
Usability testing in medical devices is an essential aspect of en...