Is your organization ready for the upcoming regulatory changes affecting medical devices and clinical trials in the European Union (EU) and the United States (U.S.)? Both the EU and the U.S. have rece...
As we reach the end of the public health emergency in the United States, healthcare professionals will revert to addressing healthcare issues such as non-communicable diseases (NCDs). At-home diagnost...
Diverse pools of participants in clinical trials are not only important for producing the best set of data, but they also help advance health equity. To reach both goals, you need multicultural commun...
In April 2022, the U.S Food and Drug Administration (FDA) released guidance requiring sponsors to create diversity plans to improve enrollment of underrepresented populations in clinical trials. Altho...
How can life sciences companies ensure that they are providing accurate, efficient, reputable translations for the communities they support? The key is to engage a language solutions partner with the ...
Developing a robust translation program is the key to supporting your limited English proficiency (LEP) customers as well as achieving global market success. These services help corporations and healt...
At long last, the European Union (EU) Clinical Trials Information System (CTIS) is ready for action. That means that on January 31, 2022, EU Regulation 536 goes into effect. Although there is a one-ye...
The European Medical Device Regulation (MDR) is an extremely daunting set of rules for medical devices within the European Union. The MDR comprises more than 100 articles, making it virtually impossib...
Although the global pandemic is not yet behind us, immense progress has been made in recent months. This would not have been possible without the thousands of clinical trials that took place. With the...
Although the COVID-19 pandemic will be remembered as a global catastrophe, it also gave rise to worldwide cooperation in order to solve the biggest medical crisis in a century. While the world is not ...
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 tec...
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, b...
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 adeq...
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 ...
Last week ULG hosted a webinar on the language-specific requirements of the European Union’s new Medical Device Regulation (MDR). Renowned MDR expert, Ronald Boumans, discussed key language-specific a...
The European Union’s new Medical Device Regulation (MDR) will begin being enforced in 2020. It seems like a long way off, but it will be here sooner than we think. The regulation, which represents a s...
This article was originally published in April 2018 and has been updated. How do you know when machine translation is right for a particular job or for your business? While some translation jobs are b...
Scientific and medical advances are often dependent on the results of research involving human subjects. This research requires significant ethical and safety considerations, and clinical trials invol...
On May 5, 2017, the European Commission released the new Europe (EU) Medical Device Regulations (MDR) in an effort to create a more unified and transparent system for medical devices. The MDR will bec...
With the resurgence of dangerous diseases such as whooping cough, malaria, and cholera, the need for clinical trials spanning the globe is stronger than ever. Diseases affect people differently depend...
The final versions of the European Union’s new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) were published in May of 2017, representing major changes to the EU’s medical d...
The misuse of prescribed medication can lead to serious health problems. Policy makers in the United States are working to implement legislation that will help put an end to the ongoing opioid crisis,...
The Regulation on Medical Devices (MDR) and the Regulation on in-vitro Diagnostic Medical Devices (IVDR) went into effect in May of 2017, effectively replacing decades-old legislation and creating new...
Anyone who’s completed a major translation project knows that it can be a costly, time-consuming process. But those with experience in the language world also know there are ways to streamline workflo...
As clinical trials have emerged in the global marketplace, Pharmaceutical Organizations and Contract Research Organizations (CROs) need to be more cognizant of the challenges that can come with transl...
In the medical device industry, regulation is a big deal. Proper training for internal operations staff, and consumer and professional end users, needs to be done effectively in order to ensure patien...
Electronic Labeling (e-labeling) has the potential to be hugely beneficial to medical device companies creating Instructions For Use (IFU), labels and packaging information. But at the same time, the ...
It seems like every time I read the Wall Street Journal, I see those four dirty words that make global corporations cringe: Foreign Corrupt Practices Act (FCPA). According to The FCPA Blog, 87 compani...
By Maurizio Suppo, Principal Consultant, Qarad Good old days will be gone forever – the new EU MD and IVD regulations are coming fast! The European regulatory framework for MDs and IVDs has been drive...
