FDA Consultant Tag

Posted By: Stephanie Bouzounis, Senior Communications Specialist Medical devices – like we mentioned in last week’s blog – fall into one of three classes: Class I, Class II, and Class III. Class I devices are low risk, and include over-the-counter items found...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The 510(k) Process In alignment with FDA’s overall vision to improve various processes, there will be updates to the 510(k) process this year. Before the updates are mentioned, a background of this necessary process for medical...

Posted By: Stephanie Bouzounis, Senior Communications Specialist February is American Heart Month, according to the American Heart Association. One of the aims of this federally designated month is to raise awareness about cardiovascular disease. The National Institutes of Health’s Heart, Lung, and...

Posted By: Stephanie Bouzounis, Senior Communications Specialist 3D printing appears to be a novel technology in popular culture, but it has been around for over three decades. What is novel, however, is its prevalence in modern medicine. What is 3D printing? The ideological...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The first month of 2018 is in the books, and for the Medical Device industry the outlook appears positive. The first big news item is the Medical Device tax. At the start of the year,...

Happy New Year from EMMA International!   Your ‘one stop shop’ for all your quality, regulatory, and compliance needs.   The new year brings with it the halo of fresh starts and new opportunities.  What hasn’t changed are the usual constraints of time, budgets,...

Hacking of the Healthcare Industry Medical devices are creating new vulnerabilities in the healthcare industry that put patient care and personal data at risk. In recent years, the healthcare industry has been hacked more frequently than the financial sector due to...