Last week, the FDA published a safety communication on how the accuracy of pulse oximeters can be affected by skin pigmentation. Specifically, there were concerns that darker skin pigmentations can considerably affect the validity of results read from oximeters, both...
In this webinar hosted from EMMA International's Manager of Technical Operations, Madison Wheeler, she gives a walkthrough of what to expect from an FDA inspection of your facility, plus the "do's and don'ts" of regulatory inspections....
If you are in the medical device industry, chances are you’ve heard of Remediation. But what exactly is it? Is it going back and just simply fixing non-compliances, is it a response to regulatory enforcement actions? The short answer is...
The FDA is in a constant state of working to optimize regulatory requirements for advancing technology. Digital health has been a hot topic for the agency over the past year due to increases in remote healthcare amidst the COVID-19 pandemic...
No matter what scope your product falls under (medical device, drug, biologic, IVD) the regulatory requirements for your Quality Management System are strict. The FDA established its various Codes of Federal Regulations to enforce that a QMS is not just...
World Cancer Day, established by the Union for International Cancer Control (UICC) in 2000, is observed every year on February 4th. Over 10 million people die each year from cancer, more than HIV/AIDS, malaria, and tuberculosis combined.1 This makes cancer a...
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...
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...
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...
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...