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CER Writing 6 min read

CER for Software as a Medical Device in the EU

The medical device industry has been changing bit by bit every day, and one of the significant changes is the addition of…

By CiteMed Author

20 Nov 2025

PMS and PMCF 9 min read

Post Market Clinical Follow Up Medical Devices: Requirements and Key Methods Under EU MDR

Under the European Medical Device Regulation (EU MDR 2017/745), manufacturers are required to conduct post-market clinical follow-up (PMCF) as part of their…

By CiteMed Author

20 Nov 2025

CER Writing 6 min read

Clinical Evaluation Report (CER) vs. Periodic Safety Update Report (PSUR)

Every medical device on the European market must be continuously monitored to confirm its safety and efficiency for patients and users. The…

By CiteMed Author

20 Nov 2025

Systematic Review 11 min read

Systematic Literature Reviews

The MDR forces manufacturers to set up processes for continuous literature reviews and reevaluation of the available clinical data. In May 2021,…

By CiteMed Author

20 Nov 2025

EU MDR 6 min read

MEDDEV 2.7.1 Revision 4: Guidelines for Clinical Evaluation

In accordance with the European directive for medical devices 93/42/EEC, ‘manufacturers must provide proof of and document the performance and safety of…

By CiteMed Author

20 Nov 2025

EU MDR 18 min read

Navigating Global Medical Device Regulations

Understanding the Landscape of Global Medical Device Regulations The global landscape of medical device regulations is as diverse as it is complex.…

By CiteMed Author

20 Nov 2025

Literature Review 7 min read

Top 10 Literature Search Tools Every Medical Writer Should Know

Medical writing is hard. It's tricky, technical, and sometimes exceptionally tedious. Suppose you chose literature reviews as your niche or form part…

By CiteMed Author

20 Nov 2025

Vigilance 6 min read

Vigilance Reporting Under the MDR: Insider’s Guide

Implementing the European Medical Devices Regulation (MDR; 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR; 2017/746) have significantly increased post-market…

By CiteMed Author

20 Nov 2025