FDA

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...

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...

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...

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...