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Latest Publications
Look here for Industry updates and technical tutorials written by the CiteMed staff. All things Medical Device Regulation are covered in our publications.
Using the IMDRF Classification to Apply Rule 11
The MDCG Guidelines recommend the application of the International Medical Device Regulators Forum (IMDRF) risk categorization framework to help with risk classification of new or unknown software through an understanding and analysis of two critical [...]
EU Clinical Trials Regulation and Reporting the Negatives in Clinical Trial Reports
The new clinical trial regulations that are in place right now will streamline applications and increase transparency. The current clinical trials regulatory framework for the European Union (EU) has entered into effect this [...]
Black Women in Science
Women remain underrepresented in science, technology, engineering, and mathematics (STEM). According to the latest report from the National Girls Collaborative Project, women make up only 34% of the STEM workforce with only 16% of engineers [...]
Performing Effective Literature Search – For EU MDR and Other Regions
For any medical device, there must be sufficient clinical evidence to corroborate compliance with relevant essential requirements for safety and performance. One of the most crucial components for a thorough and complete Clinical Evaluation [...]
The EU MDR Implementation Date and the Impact of Covid 19 Pandemic
Making a medical device means you're in the business of saving lives—and that's nothing to sneeze at. As if that wasn't enough pressure, you now have to deal with the labyrinthine EU certification process. [...]
EU MDR Checklist Download – Get Actionable Technical Documentation Requirements
The European medical device regulations (MDR) provide a minimum standard in Europe for health equipment manufacturing or exporting. We know it is hard enough to remember the new changes and guidelines when it comes to MDRs. Keeping [...]