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 ...
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...
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 inv...
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 b...
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...
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 crisi...
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 n...
