Usability Testing in Medical Devices: A Comprehensive Guide
Usability testing in medical devices is an essential aspect of ens...
Developing and Maintaining a QMS for IVDs
In vitro diagnostics (IVDs) are vital for detecting diseases, cond...
Clinical and Non-Clinical Compliance: Regulatory and Quality Requirements
Regulatory submissions of clinical and non-clinical datasets play ...
Key Considerations When Choosing a CDISC SEND Service Provider
In today’s fast-paced regulatory environment, choosing the r...
Residual Risk Analysis and User Interaction Problems: Risk Management Under EU MDR
Under the EU MDR, Risk is defined as the combination of the probab...
MDCG Issues Guidance on Investigator’s Brochure for Medical Device Studies
The Medical Device Coordination Group (MDCG) is a regulatory body ...
