Meeting and maintaining FDA compliance standards can be a challenge for even the most seasoned organization. Receiving...
EMMA International, A Leading Life Sciences Consultancy, Announces Major Rebranding
Bingham Farms, MI, June 7, 2020 –EMMA International, a global leader in Quality and Regulatory consulting, is excited...
Enforcement Mechanisms Available to the FDA
The mission of the Food and Drug Administration is to protect public health by ensuring compliance of products and...
EMMA International Consulting Group, Inc. Ranks No. 96 on Inc. Magazine’s List of the Midwest’s Fastest-Growing Private Companies
Bingham Farms, MI, March 16, 2021 –E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader...
EMMA International Consulting Group, Inc. Appoints New Members and New Chairwoman to their Board of Directors
Bingham Farms, MI, March 8, 2021 – E.M.M.A. International Consulting Group, Inc. (EMMA International), a global leader...
What to Expect When You’re Inspected
In this webinar hosted from EMMA International’s Manager of Technical Operations, Madison Wheeler, she gives a walkthrough of what to expect from an FDA inspection of your facility, plus the “do’s and don’ts” of regulatory inspections.
The FDA’s Action Plan for AI-ML-Based Software As A Medical Device
In this webinar hosted from EMMA International’s Software Engineer, Govind Yatnalkar, he focuses on the recently released FDA’s action plan for regulating AI/ML-based software as a medical device (SaMD). He then dives into the five major action items provided in the action plan along with examples that define the actual regulation strategies for AI/ML-based SaMDs.
Industry 4.0 and Medical Devices
As we progress through the 4th Industrial Revolution, technology is advancing quicker and quicker. More and more...
Regulatory 101 for Medical Device Start Ups
In this webinar hosted from EMMA International’s Lead Quality Engineer, Nikita Angane, she will go over the different FDA Centers, as well as the pathways to market, what a RTA (Refuse to Accept) is, and also reviewing labeling, registration, and device listings.
AI and ML in Software as a Medical Device
In this webinar, we will be covering what exactly an SaMDs, or Software as a Medical Device, and go over some examples with Artificial Intelligence. We will also look at Artificial Intelligence and Machine Learning versus the traditional software. Next, we will go into the regulatory framework for these types of software, then explain how EMMA International can help you get your SaMD to market.
Building a QMS for Your SaMD – Part II
In this second part of the webinar, we will review how to tackle changes that were made to the software post market, the verification and validation activities for your software, regulatory clearance of changes made to the software post market, and how to handle software recalls.
MDSAP – What it Means to Your Business
This webinar will explore the Medical Device Single Audit Program, or MDSAP. We will provide an overview of the program, including how the audit is conducted and what regulatory requirements are included. We will also explore what the MDSAP audit could mean for your business as far as marketing options in other countries, as well as compliance risks to medium and small size companies. Finally, we will review lessons learned with real-life (i.e. field) examples to help you understand and prepare for the audit.