As the impact of the pandemic is still very much affecting everybody throughout the globe, it has generated profound disruption across the digital health sector. Although COVID-19 has created change i...
Innovation is the ability to see change through an opportunity. It's the true driving force that sits behind the medical device industry, and it's what saves more and more lives each and every year. M...
Electronic Clinical Outcome Assessment, more commonly known as ECOA, revolves around the procedure of capturing data electronically in clinical trials, as opposed to on paper. Many state that eCOA is ...
In today's world, consumers have a constant expectation to receive things instantly. Whether this is through Prime on Amazon, or free next-day delivery from the billion stores on the web - digital t...
Throughout the numerous lockdowns that the COVID-19 crisis induced upon us all, remote personal interaction became the new normal. It's what reduced potential exposure for everyone around the world,...
Medical devices are a vital healthcare innovation. They exist to monitor, replace, or modify anatomy or physiological processes, and improve patient outcomes throughout the means. However, if not ad...
Technical translations of your content can be daunting and costly if approached the wrong way. A wrongly executed content translation strategy may result in high expenses, inconsistency, and an over...
In the third and final webinar of the series with Ronald Boumans, senior consultant for regulatory affairs at Emergo by UL we learned on the importance of Summary of Safety and Clinical Performance (S...
If you are anything like us, you’ve experienced steady changes with the continuously evolving MDR requirements. In 2020, the new European Medical Device Regulation (MDR) was rolled out. These guidelin...
European Medical Device Regulation (MDR) is continuously evolving, making it difficult to keep up with all of its requirements. It is important to understand these guidelines to ensure that your medic...
It has now been a year since the European Union’s new Medical Device Regulation (MDR) enforcement. It may seem like a long time ago, but there is still work to be done and regulations to understand so...
The International Organization for Standardization (ISO) is the world’s leading quality control organization that sets standards related to manufacturing, product labeling, and safety. Many companies ...
