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On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / Machine Learning (AI / ML) based Software as a Medical Device (SaMD) and is taking public comments on the proposal until June 3, 20191. T...

Does a Human Factors/Usability Engineering (HFE) validation study need to be completed for your medical device?  If your Risk Management process is not integrated with HFE, how and when to integrate it into the product development process can be imp...

With the initial Brexit plans derailed and the deadline now being extended to April 12th, the trade and manufacturing industry is in a state of chaos. The constantly changing regulations have put the stakeholders in a difficult situation. In preparat...

3D printing has a multitude of applications in the medical device field. Right from the inception of the additive manufacturing technique, engineers have been working on how this technology can serve the health care industry. Additive manufacturing h...

Outstanding innovations come with the heavy burden of dealing with new risks and threats. Especially when public health is at risk, FDA and other regulatory agencies attempt to provide guidance for companies to develop safe and effective products. Wi...

With the mounting tensions that the new EU MDR has put on medical device manufacturers, the ripple effects can be seen in every department at those medical device companies. By default, the regulatory affairs functions have been the worst hit and are...

With the new EU MDR, companies must comply with several new requirements. Our previous blogs gave a snapshot of what has changed in the new EU MDR and how as a Medical Device manufacturer you can best deal with these changes. You can read some......

The three-year transition period to the EU MDR does not only engage the Regulatory Affairs personnel in Medical Device companies but also the entire business leadership as well. Companies are still in the three-year transition period to comply with t...

The government has temporarily “re-opened” until Feb 15th after the longest government shutdown in US history that lasted for 35 days. Here’s what’s going to happen: Some FDA officials carried out inspections and other critical activities wit...

The field of mobile medical applications (apps), software that run on smartphones or other mobile communication devices, has grown incredibly in both the number of applications available and the nature of the medical application. In this article, we ...

The new EU MDR is set to go into effect in May 2020. The transition to the new regulations is burdensome for some companies especially because of some newly established requirements. One such requirement is to have a Person Responsible for Regulatory...

With the fast approaching Brexit date, the possibilities of Britain exiting the EU without striking a deal are very high. Prime Minister Theresa May’s exit agreement was rejected by the British Parliament on January 15, 2019, by 432 votes to 202. T...

In contrast to 2014, news on the Ebola virus today is relatively minimal. However, Ebola outbreaks are still occurring, most recently in the Democratic Republic of Congo. This article reviews the response of the U.S. FDA to the Ebola virus and progra...

FDA is not the only organization that can review 510(k) submissions. Under the Third Party (“3P”) Review Program, 510(k) submitters can voluntarily send their 510(k) to recognized organizations (“3PROs”) for review. This article provides an o...

We witnessed several changes in the medical device industry in the year 2018. The impact of some changes was hard-hitting while some were received with a warm welcome by industry professionals. It sure is a difficult and confusing time for the medica...

Medical Device manufacturers selling their devices in the European Union are currently in a three-year transition period to comply with the new EU MDR 2017/745. There are quite a few changes proposed in the new regulation that medical device companie...

The FDA’s 510(k) process for medical devices is doing a lot of rounds in the news lately. This includes the FDA Commissioner Dr. Scott Gottlieb’s announcement on the renovation to the 510(k) program1 and two new pilot programs initiated by FDA: t...

The revision of the Quality System Regulation [QSR] (21CFR 820) which was a priority set in FDA’s Spring unified agenda also made it to the FDA’s Fall unified agenda published in October 2018.1 The revision will replace the existing regulation i...

The digital health software pre-certification program is FDA’s strong footstep in leading the way to support the inclusion of the digital world in the US healthcare industry. As part of FDA’s digital health innovation action plan, the pre-cert pr...

Medical devices in the UK are regulated by the directives put forth by the EU, including: Active Implantable Medical Devices Directive (AIMDD) Medical Devices Directive (MDD) In Vitro Diagnostic Medical Device Directive (IVDD)   High risk medica...

In a previous blog from a few months ago on the update in the De novo pathway, we shed some light on the prices introduced through the MDUFA IV for the De Novo process. Additionally, the blog discussed how the release of the FDA guidance......

Paper Based QMS vs EQMS When looking at a document management system, companies have two choices; paper based or electronic. In our experience, companies often tell us that, ‘they have been talking about an EQMS’ for a significant amount of time ...

E.M.M.A. International Consulting Group, Inc. (EMMA International) a global leader in quality, regulatory, and compliance services for the Biotechnology, Pharmaceuticals, and Medical Device industries, is pleased to announce the opening of its newest...

Independence Day is a time to celebrate our country with family and friends. July 4th is synonymous with fireworks, swimming and picnics. However, the fun of picnic and barbeque season can also bring on additional opportunities for foodborne bacteria...

Overview The opioid epidemic can be traced back to the late 1990s, when the medical community began to prescribe opioid pain relievers at a higher rate due to the information and reassurance they received from the pharmaceutical companies that patien...

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 EMMA 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), t...

EMMA 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 the...

Spring is off to a great start for EMMA 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 projec...

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...

EMMA 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 colleagues a...

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 EMMA 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 Single ...

First, EMMA 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 13485:20...

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......