Medical devices can range from complex machines to simple products like band-aids; however, one constant among them all is that they should be designed in such a way that reduces the risk of human use error as to as low...
The FDA revised its guidance document ‘Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications for Medical Devices — Questions and Answers’ which was originally released in June, to give device sponsors additional time in...
Clustering is one of the modern approaches to segregate and group data based on similar attributes. It is utilized in many cutting-edge technologies such as AI (Machine Learning) and Cloud Computing to derive key hypotheses, analysis, and add intelligence to...
COVID-19 vaccines have now been approved for a few weeks, and nearly 2 million people in the United States have received their first dose of the vaccine.1 This is excellent news, but you may be wondering what the next step...
Tears in the anterior cruciate ligament (ACL) are one of the most common sports injuries every year. Despite being extremely common, up until recently the only way to treat an ACL tear was to perform ACL reconstruction, which typically utilizes...
Data mining is the field of Computer Science that forms the basis for data analytics. As the term specifies, it is utilized for ‘mining’ or extracting the most significant data from ‘Big Data’ or massive data sets. It not only...
If you are in the Life Sciences Industry you have heard of FDA Guidance Documents, and specifically, if you are in a business where you have had to have some interaction with the FDA, you have likely made use of...
Part 2 of the Canadian Medical Devices Regulations under the Food and Drugs Act allows for health care professionals to request the use of custom-made and unlicensed medical devices on patients.1 To be eligible to receive this special access, the...
One of the FDA’s initiatives for 2021 is to streamline the 510(k) pathways, allowing more efficient access to new medical technologies. Part of this streamlining is enhancing the Safety and Performance Based Pathway, which is an alternative route to traditional...
The EU regulators delayed implementation of the EU MDR by a year with its new date of application now being May 26th,2021. However, Article 59 of the EU MDR went into effect on April 24th,2020, and also encompasses the EU...