Blog

What is FSMA? The FDA Food Safety Modernization Act (FSMA) was signed into law by President Barack Obama in 2011. This enables the Food and Drug Administration (FDA) to provide oversight, ensure compliance with requirements, and respond effectively t...

Posted by Stephanie Bouzounis, Senior Communications Specialist   Daily consumers use and consume products that have the potential to harm or enhance their health. Medications, food, and medical devices are all regulated by the Food and Drug Adm...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The AIDS (Acquired Immunodeficiency Syndrome) crisis in the early 1980s had a profound effect on blood donations. The perception that the blood supply was safe changed in the mind of t...

Posted By: Stephanie Bouzounis, Senior Communications Specialist Technology and health care have converged in the 21st century under the umbrella of what is known as digital health. What is digital health? The 21st century has seen the convergence o...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The deadline for the ISO 13485:2016 transition is fast approaching. In less than a year from now, changes will have to be made in order for companies to keep their certifications. Back...

Posted By: Stephanie Bouzounis, Senior Communications Specialist The European Union (EU) published a new Medical Device Regulation in May 2017, giving manufacturers three years before full implementation in 2020. There are several changes in this ne...

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-cou...

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 bac...

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. Th...

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 ...

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, i...

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 const...

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 financia...

Spring conference season is upon us and E.M.M.A. International has just finished an exciting month of conferences with some incredible organizations we work closely with. If you are not familiar with the Medical Device Manufacturers Association (MDMA...

E.M.M.A. International Consulting Group, Inc., is proud to be a Silver Sponsor of The Manufacturer’s Association of Central Pennsylvania’s 2017 Annual Event.  This year we will be offering one (1) complimentary ticket to the Annual Event to...

Spring is off to a great start for E.M.M.A. International! We are beginning this spring season by offering a new, unique service to those looking to find direction for their quality and regulatory needs. If you’re not sure where you stand with a pr...

MDSAP-What Manufacturers Need to Know In 2014, the International Medical Device Regulators Forum (IMDRF) launched the Medical Device Single Audit Program (MDSAP) pilot. As of 2017, the MDSAP is in full force and fully operational. This poses the ques...

E.M.M.A. International was incredibly pleased to have hosted dozens of regional business leaders and innovators at our headquarters in Farmington Hills this month. Our ‘Meet & Mingle’ events are a great way to stay connected with colleagu...

A recall can make all consumers especially nervous, but for a company issuing such an action, this can be evermore daunting, though it doesn’t need to be. A recall is essentially a removal of a product from the market for a defect or other issue......

President Donald Trump, in his first few weeks in office, has been forging ahead with executive orders, making good on promises made while campaigning. He has signed one such executive order (EO), “Reducing Regulation and Controlling Regulatory Cos...

Do you want the world to see your dirty laundry?  If not, then E.M.M.A. International can help you prepare for the new Medical Device Single Audit Program (MDSAP). MDSAP full implementation is in effect as of January 1, 2017. The Medical Device Sin...

First, E.M.M.A. International would like to wish everyone a wonderful and prosperous new year.  However, we know that a new year can also bring new challenges. In 2017, you can: Transition from ISO 9001:2008 to ISO 9001:2015 Transition from ISO 1348...

Like many industries, progress within the medical field depends on innovation. This innovation has produced novel technologies and medical device improvements that rely increasingly on data storage, software, networks, and user devices. The scale and...

A need to have an effective and modern approach for a pharmaceutical Quality Management System (QMS) resulted in the International Conference on Harmonization (ICH) developing a new quality system guidance that has the ability to support the regulato...

In 2007, several high-profile drug safety problems triggered Congress to mandate the FDA to develop an active surveillance system, utilizing electronic health data, to improve tracking and analysis of drug safety after drugs reach the market [1]. Dur...

In Back to Basics: Complaint Handling – Part I the basic requirements for complaint handling were discussed and we left off at the topic of MDRs. From a high level, a MDR is a post-market surveillance activity required by the FDA to monitor devic...

In today’s fast paced society, innovation and progress are the name of the game, especially in the medical device industry. However, placing so much pressure on the development of new technology puts resolving issues associated with products, alrea...

Imagine, for the last five years you have worked to design a new, low-risk medical device and you are now ready to submit a 510(k) to the FDA for market approval. You do your due diligence to demonstrate the safety and effectiveness of your device......