Cloud Computing is speeding up the way we create, share, and view data. With features such as multiple backups, high security, remote access, and auto-scalability, this platform of virtual computing is assisting health care providers and medical device manufacturers to...
If you have ever wondered exactly what role the FDA has in mammography and breast cancer screening, you are not alone. How the FDA regulates technology such as this can get complicated easily when you consider all the different aspects...
The US FDA introduced a new form of certificate referred to as the Certificate for Devices Not Exported from the US (CDNE). These certificates are for devices not manufactured in the US and hence are not eligible for export certificates...
Many people had to transition to a remote work environment amidst the COVID-19 pandemic, with Notified Bodies being no exception. This meant that medical device companies had to be audited virtually, which left many unsure as to how successful a...
The EU MDR and the IVDR layout the performance and safety requirements for medical devices and In-vitro diagnostics respectively in the EU. According to Article 8 of the EU MDR and the IVDR, manufacturers that comply with the harmonized standards...
The platform of Robotics facilitates automation in any industry. It uses various streams of Engineering including Computer Science, Electrical, and Mechanical, and is primarily used to build intelligent machines where human safety is of major concern. Generally, the major components...
For the past few decades, the FDA has been attempting to increase the diversity of individuals participating in clinical trials. Specifically, they are trying to encourage any companies conducting clinical trials to include the demographics that will primarily be using...
If you are a part of the medical device industry, you are probably familiar with just how many “must know” acronyms exist. Three of the most important, and most often confused, acronyms are DHF, DMR, and DHR. The Design History...
Manufacturers that export FDA-regulated products such as drugs and medical devices from the US are oftentimes required to provide a certificate prepared by the FDA which confirms the product’s regulatory and marketing status.1 In most cases, the foreign regulatory body requires...
Medical devices keep evolving, and with cutting edge technologies such as AI and Cloud, they are continuously adding quality to the overall patient care. Being in the medical sector, where the patient and their care is always a priority, manufacturers...