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...
Usability Testing Procedure and Regulations
Usability for medical devices is a part of risk management and re...
Developing and Maintaining a QMS for IVDs
In vitro diagnostics (IVDs) are vital for detecting diseases, con...
Residual Risk Analysis and User Interaction Problems: Risk Management under EU MDR
Under the EU MDR, Risk is defined as the combination of the proba...
Responsibilities for Medical Devices Vigilance Reporting
Medical devices are regulated differently across the globe. Each ...