The US Food and Drug Administration has the responsibility to ensure that medical devices being imported into the US comply with the applicable regulations. A foreign manufacturer, defined as a manufacturer located outside of the US, must comply at a...
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...
Are digital applications better than paper-based systems? Without a doubt, yes. Applications replace large cabinets of paper storage with a small computer. They not only save space and paper but also offer quick data or document search with easy updates....
Where do you feel you have the best digital user experience? A web or a mobile app? I have been a web developer for almost four years, but still, I prefer the Amazon app to order gadgets instead of the...
The FDA released an information transmittal to the MDSAP Auditing Organizations on December 31st, 2020 providing further guidance on the expansion of remote MDSAP audits during the period of the public health emergency.1 Under this transmittal order, FDA clarifies the difference...
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...