Quality

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...

If you are a manufacturer of a radiation-emitting medical device, then 21CFR 820 is not the only regulation that you need to comply with. Title 21 of the Code of Federal Regulations, Parts 1000 through 1050 (21 CFR 1000 –...

EMMA International celebrates February in recognition of American Heart Association Month and we bring you an interesting blog on the 8 types of medical devices that perform heart-related element monitoring and essential actions in case of heart-related diseases. The first device...

While going through my daily tech-news, I came across an interesting piece of research relating to 3D printing. Scientists at the Tel Aviv University, Israel, 3D printed the world’s first human heart using actual human tissues.1 I knew the basic definition...

Quality and performance standards are revised every three to five years, or sometimes sooner, depending on the industry need. European regulations accept European specific versions of ISO standards when assessing conformance of the product and the organization’s quality management system. The...

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...