Quality Systems

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...

Nowadays, there are mobile applications for almost every utility and in every domain. From e-commerce, finance, education, food-industry to healthcare, mobile applications provide impeccable services as these software tools in our mini-computers provide the best user experience and equivalent internet...

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...

In light of the COVID-19 pandemic, the EU commission adopted the Regulation (EU) 2020/561 that deferred the application of the EU Medical Device Regulations, which were set to go into effect in May 2020 by a year. This also means...

As medical device firms adjust to the new normal in light of COVID-19 hurdles, the FDA continues to issue guidances and relax regulatory requirements to accommodate. Disruptions to global supplies and the challenge of social distance restrictions may be the...

In an effort to accelerate the production of tests for COVID-19, FDA released a new guidance document that will allow for clinical laboratories and commercial manufacturers to accelerate the development of COVID-19 tests. In this guidance document, FDA outlines its...