The Importance of Risk Management for Medical Device Manufacturers

What is a Clinical Evaluation Plan and Why is it Important?

CE Mark for Medical Devices What You Need to Know to Stay Ahead in the Industry

Unraveling the Relationship between EN ISO 14971:2019/A11:2021 and the General Safety and Performance Requirements of Regulation (EU) 2017/745 & 2017/746

Amended transition timelines of Regulations (EU) 2017/745 and (EU) 2017/746

European Commission to consider extensions to MDR and IVDR deadlines?

Quantification of Benefit – Risk Analysis

The routes to conformity

Clinical Development Plan (CDP)

Identification and Traceability in Medical Device Industry