The FDA’s process for drug development can be a lengthy, and often expensive, commitment. If you are developing a new drug product from the beginning, it is critical that you understand the phases of the development process and the deliverables...
Happy National Blood Donor Month! We celebrate the first month of the year as the National Blood Donor Month, and in honor of that we are highlighting a recently FDA-cleared Blood Establishment Computer Software (BECS), the SoftBank Version 25.6.1.0, also...
Health Canada recently published SOR/2020-262 amending the Food and Drug Regulations and the Medical Devices Regulations (CMDR). The amendments under these regulations strengthen Health Canada’s ability to collect post-market safety information in support of Vanessa’s Law (Protecting Canadians from Unsafe...
Artificial Intelligence (AI) is the branch of Computer Science that provides the ability for computing systems to solve human problems. One of the major subsets of this field is Machine Learning (ML) which provides recommendations or decisions by continuously learning...
Every year over 14,000 cases of cervical cancer will be diagnosed and over 4,000 people will die from cervical cancer in the United States alone.1 Cervical cancer is one of the most common causes of cancer death for women, and as...
We reside in a modern world where digital health services are available and can be accessed online instantly. Despite the apparent abundance of resources, there are still cases where hospitals or blood banks run out of essential resources, such as...
January 12th is celebrated as National Pharmacist Day to recognize all the pharmacists across the nation. In addition to surgeons, nurses, and paramedics, this is another profession that contributes immensely to the health care industry. Historically, pharmacists only dispensed prescribed...
The FDA’s Breakthrough Devices Program is for certain medical devices that provide treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.1 This particular pathway is reserved for devices with unique and other-wise unavailable treatments to serious conditions, but what...
The Medical Device Single Audit Program covers the compliance requirements of the USA, Brazil, Japan, Canada, and Australia. Although this program does not cover the requirements of the EU, which is the EU MDR and IVDR, a guidance document released...
The term “wireless” in Industry 4.0 is not limited to only wireless communication; it is backed up by modern technologies such as the Internet of Things (IoT) and Cloud Computing for effective and robust system functionality. In the health and...