Maria DiBari

Maria DiBari is a consulting partner for 1SmartQMS LLC, helping companies bridge quality gaps, remediate compliance issues, and build out quality management systems from the ground up. With over 18 years of experience in medical device R&D and manufacturing, pharmaceutical manufacturing, and A.I. health software application development, she brings unparalleled expertise and a wealth of experience to the forefront. Maria brings a wealth of experience to medical device compliance, auditing, quality assurance, validation, and artificial intelligence. A graduate of the State University of New York-New Paltz, she holds a Bachelor of Science and a Master’s degree in molecular biology. She is a quality expert in the application of regulations such as 21 CFR Part 11, 21 CFR 820, and 21 Centuries Cures Act. As an executive leader in validation remediation, quality strategy development, strategic executive engagement, and team management, Maria provides guidance to executive management on the strategic development of health software applications. LinkedIn Profile: https://www.linkedin.com/in/mariadibariphelps

Email [email protected] for more information.

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Software

Building a Framework for Machine-Learning Compliance in Regulated Industries

Transparency is challenging when developing machine-learning algorithms.

Maria DiBari Alonso Diaz

October 1, 2024

Regulatory bodies like the FDA and MHRA are adapting guidelines to accommodate the evolving AI landscape, stressing the importance of innovative compliance approaches alongside traditional software regulations, including audit trails, electronic records, and signatures.

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Management

The Price of Excellence: Understanding the Value of Quality, Part 2

Companies that strive for quality and their business goals are likely to achieve both.

Alonso Diaz Maria DiBari

March 19, 2024

Management feature image of Quality inspector and manual worker in a factory.

Management | Value of Quality 2-part Series

The Price of Excellence: Understanding the Value of Quality, Part 1

When a company makes quality a primary goal the benefits outweigh the risks.

Alonso Diaz Maria DiBari

March 12, 2024

Quality is a critical competitive priority for organizations. It is the foundation for a competitive advantage, even when firms prioritize other operational considerations. However, it is often de-prioritized during financial stress, leading to financial, customer, and workforce issues.

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Management

Activating Creative Leadership and Collaborative Teams

Tools for fostering synergy and cultivating collaboration at your company.

Maria DiBari Alonso Diaz

February 14, 2024

The pandemic has forced a shift in business models, with companies relying on digitization and remote working to cut costs and improve efficiency. Collaborative trends are on the rise, with teams collaborating performing five times better than those who don't.

Previously known as Informa Markets Engineering (IME) West, hosting five co-located shows — MD&M West, ATX West, D&M West, Plastec West, and WestPack — we are now merging 4 of these related industry sectors into a single unified show: MD&M West.

Our special focus on your specialty is not changing. One MD&M umbrella unites a community of multiple special interests who all share a single goal – to advance their knowledge, contacts, and progress in the rapidly accelerating world of advanced manufacturing.

Maria DiBari

ARTICLES