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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.
Can Artificial Intelligence Technology Tame Literature Review?
When one tries to publish in an international journal these days, they inevitably encounter an obstacle: researchers around the world have more than likely published thousands of papers on a similar topic, which could need [...]
IVDR: General Principles of Clinical Evidence for In Vitro Diagnostic Medical Devices (IVDs)
A year into the EU Medical Device Regulation (MDR 2017/745), it is safe to say the implementation of the MDR has been complicated, for both manufacturers and the notified bodies. Even though the European Parliament [...]
The Relationships Between Literature Search and CER and PMS Vigilance, PMCF, and PSURs
A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices. The [...]
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 EU MDR (2017/745) requires clinical evaluation and post-market surveillance programs to ensure [...]
World Health Day – April 7, 2022
Initiated by the World Health Organization and celebrated by all, each April 7 is recognized worldwide as world health day! This April 7 is no different. Each year, on this day, the World Health Organization [...]
Managing Clinical Evaluation Report (CER) and Literature Review Teams
Being a medical device manufacturer involves more than the actual manufacturing of the medical devices. A manufacturer's job is not only to come up with a device that will be beneficial to the patient [...]