The Future of Enterprise Quality Management Software (EQMS) – Part I

by | Aug 17, 2018 | FDA, ISO, Medical Devices, QMS

The future of enterprise quality management software is changing. Quality professionals across the globe are dealing with an astounding number of changes that correspond with new international standards and regulatory requirements, including the transition to ISO 13485:2016, ISO 9001:2015, IATF 16949:2016, as well as the upcoming transition to the new EU Medical Device Regulation (MDR). Additionally, FDA, in the recent Spring Unified Agenda, made it clear that the future goal is to harmonize and modernize regulation of Medical Device Quality Systems. The primary objective is to “reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements”.

The noted changes in the international regulatory landscape will have a direct impact on quality management system (QMS) design and implementation. Thus, this is an appropriate time to reveal a new approach to QMS thinking and analysis that will undoubtedly pave the way to the future of QMS architecture. With that said, the purpose of this white paper is to introduce some new and innovative concepts that are aimed at taking our current thinking into the future. And yes, this includes incorporating Artificial Intelligence into the design and architecture of a QMS.

In this paper, we will discuss:

  • The history and evolution of quality systems and Enterprise Quality Management Software (EQMS) platforms
  • The concept of a Self-Learning QMS, and the concept of Intelligent EQMS
  • The new QualiMeter tool and the associated unit of measurement (quality process interactions (QPI))
  • The role of artificial intelligence in the future of EQMS platforms.

Get the The Future of Enterprise Quality Management Software Part 1 Whitepaper

Fill out the form below, and the webinar will get sent directly to your inbox.
Carmine Jabri

Carmine Jabri

CEO - As co-founder of E.M.M.A. International Consulting Group, Inc., Carmine Jabri, PhD, MSJ, MSQM, MHA serves as EMMA International’s CEO. Dr. Jabri is an experienced Quality Assurance & Regulatory Affairs professional with more than twenty years of experience implementing, improving, and directing Quality Management Systems and compliance operations. His career includes expertise in the Pharmaceuticals, Medical Device and Biologics industries. Dr. Jabri serves on the Food and Drug Law Institute’s Medical Products committee and is an internationally sought-after quality systems expert. Dr. Jabri holds a Doctor of Philosophy in Epidemiology, a Master of Science in Jurisprudence, a Master of Science in Quality Management, a Master of Science in Health Services Administration, and a Bachelor of Science in Chemistry.

More Resources

Abbreviated 510k submission

Abbreviated 510k submission

There are three types of 510K, Premarket Notifications, which can be submitted to the Food and Drug Administration (FDA) traditional, abbreviated, and special. Abbreviated and Special 510K submissions can be utilized when the submissions meet the certain factors presented by the FDA. When submitting an abbreviated 510K the submission must include the elements that are identified in 21CFR 807.87 for the information required in a premarket notification submission.
Is your product a medical device?

Is your product a medical device?

Many marketed products are classified as medical devices and you would not even know it. Medical devices range from latex gloves and tongue depressors to respirators and heart valves. To determine if the product is considered a medical device by the Food and Drug Administration (FDA) you will need to analyze if your product meets the definition of a medical device per the Food, Drug, and Cosmetic Act1.
Sterilization of Medical Devices

Sterilization of Medical Devices

There are many ways to sterilize medical devices before use in the industry. The common methods utilized are steam, radiation, dry heat, ethylene oxide, and vaporized hydrogen peroxide. There are two methods of sterilization for medical devices recognized by the Food and Drug Administration (FDA), established and novel.

Ready to learn more about working with us?

Pin It on Pinterest

Share This