Latest Publications

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

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 [...]

  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. [...]

 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 [...]

The work of a literature review is not merely to be submitted as a part of the submission document. A good literature review can do half of the job for the marketers developers alike, all [...]