Blog

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......