Our Best MDR Whitepapers and Templates
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Medical Device Clinical Evaluation Reports under EU MDR
Your NB’s Clinical Evaluation Assessment Report
MDCG’s Guidance document, released in July 2020, introduces and details the key requirements and format of a Clinical Evaluation Assessment Report (CEAR) to be documented by Notified Bodies (NBs) as a part of its [...]
An Understanding of the Clinical Evaluation Process in China – Comparison with EU MDR
Medical device regulations in China are often likened to the European Union (EU)’s MDR, with a vital prerequisite of Clinical Evaluation Reports (CERs), as required by China’s National Medical Products Administration NMPA (formerly CFDA). [...]
Post Market Clinical Follow-Up (PMCF) – Understanding MDCG’s Latest Guidance
PMCF Guidance An important constituent of Post Market Surveillance (PMS), Post Market Clinical Follow Up (PMCF) is a continuous lifecycle process, wherein the device’s clinical evaluation is constantly updated, confirming its safety and clinical [...]
Medical Device Literature Search and Review under EU MDR
How to Hire a Literature Search Writer and What to Look For
With the upcoming transition to the Medical Device Regulation (MDR) 2017/745 in May 2021, medical device manufacturers are facing constant monitoring and life-cycle management of their clinical data. In the European Union, the Clinical Evaluation [...]