Rockwell Medical Advances Quality and Regulatory Leadership

Key Terms

design controls technical

A documented, systematic set of procedures that guide how a product is conceived, designed, tested, and finalized to meet specified requirements and safety standards. Like a recipe plus quality checklist, design controls record requirements, design reviews, testing, verification and validation, and risk management so regulators can trace how a product was developed; investors care because strong design controls affect regulatory approval, product reliability, development timelines, and potential liability or recall risk.

quality systems technical

A quality system is the organized set of policies, procedures, records and controls a company uses to ensure its products or services meet regulatory standards and customer expectations. It covers everything from design and production to testing, complaint handling and internal audits, like a recipe book and checklist that keeps processes consistent. Investors care because effective quality systems reduce the risk of recalls, fines, production delays and reputational damage that can affect earnings and valuation.

class i, ii, and iii medical devices regulatory

A regulatory system that groups medical devices by the level of risk they pose and the amount of evidence and oversight required before and after they reach the market: Class I covers low-risk items with basic controls (like bandages), Class II covers moderate-risk devices that need specific performance testing and standards (like imaging equipment), and Class III covers high-risk, life-supporting devices that require the most rigorous clinical data and premarket review (like implanted devices). For investors, the class affects how long and costly it is for a company to develop, gain approval for, and sell a device, similar to how a building permit varies depending on whether you’re putting up a shed or a hospital wing.

project management professional (pmp) technical

A Project Management Professional (PMP) is a widely recognized certification for people who plan, organize and lead business projects. For investors, a PMP indicates that managers are trained to keep projects on schedule, on budget and aligned with goals—similar to hiring an experienced conductor to keep a complex orchestra playing together—reducing execution risk and improving the odds of delivering expected returns.

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Names Brian Cox Vice President, Quality and Regulatory Compliance

WIXOM, Mich.--(BUSINESS WIRE)-- Rockwell Medical, Inc. (the "Company") (Nasdaq: RMTI), a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products to dialysis providers worldwide, today announced that Brian Cox has joined the Company as Vice President, Quality and Regulatory Compliance.

Brian Cox - Vice President, Quality and Regulatory Compliance at Rockwell Medical, Inc.

Mr. Cox brings more than 20 years' healthcare experience spanning medical device development and manufacturing, quality, regulatory compliance, operations, and program management. His background includes senior roles at large global healthcare companies, including Abbott and Johnson & Johnson, as well as smaller, growth-oriented medical device manufacturers, giving him a broad perspective on how to build and scale quality systems in complex regulated environments.

“We continue to evaluate opportunities that expand our capabilities, broaden our product portfolio, and serve additional areas of the renal care market," said Mark Strobeck, Ph.D., President and CEO at Rockwell Medical. "As we advance these priorities, it is critical that we continue to invest in compliance, quality systems, and the regulatory capabilities required to support our long-term vision. Brian's extensive experience building and leading world-class quality and regulatory organizations will help ensure Rockwell continues to uphold the highest standards of product quality, safety, and compliance as we execute on our growth strategy."

Throughout his career, Mr. Cox has led cross-functional teams responsible for quality systems, regulatory readiness, audit oversight, product development, program management, and design controls. Additionally, he has domain expertise in Class I, II, and III medical devices, regulated manufacturing environments, product launch readiness, and governance frameworks that support innovation, organization scalability, regulatory compliance, and long-term growth.

“Rockwell Medical has built a reputation for quality, reliability and high-touch customer service that serves as a strong foundation for future growth and innovation," said Mr. Cox. “I am excited to join the Company at a pivotal point in the Company's history as it continues to strengthen its leadership position within the dialysis marketplace. I look forward to building on Rockwell's unrelenting commitment to quality and regulatory excellence, while ensuring our systems and processes support innovation, scalability, and the long-term needs of customers and patients.”

Mr. Cox holds a Master of Information Systems from George Washington University, a Master of Business Administration from the University of Texas at Arlington, and a Bachelor of Science from St. Louis University. He is also a certified Project Management Professional (PMP) through the Project Management Institute.

About Rockwell Medical
Rockwell Medical, Inc. (Nasdaq: RMTI) is a healthcare company that develops, manufactures, commercializes, and distributes a portfolio of hemodialysis products for dialysis providers worldwide. Rockwell Medical's mission is to provide dialysis clinics and the patients they serve with the highest quality products supported by the best customer service in the industry. Rockwell is focused on innovative, long-term growth strategies that enhance its products, its processes, and its people, enabling the Company to deliver exceptional value to the healthcare system and provide a positive impact on the lives of hemodialysis patients. Hemodialysis is the most common form of end-stage kidney disease treatment and is typically performed in freestanding outpatient dialysis centers, hospital-based outpatient centers, skilled nursing facilities, or a patient’s home. Rockwell Medical's products are vital to vulnerable patients with end-stage kidney disease, and the Company is relentless in providing unmatched reliability and customer service. Certified as a Great Place to Work^® four years in a row (2023-2026) and named Fortune Best Workplaces in Manufacturing & Production™ in 2024 and 2025, Rockwell Medical is Driven to Deliver Life-Sustaining Dialysis Solutions™. For more information, visit www.rockwellmed.com.

Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as, "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "can," "would," "develop," "plan," "potential," "predict," "forecast," "project," "intend," "look forward to," "remain confident," “are determined,” “are on track,” “are resolute in our vision,” "work to," "drive towards," “focused on,” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward looking statements. Such statements include statements relating to ensuring Rockwell continues to uphold the highest standards of product quality, safety, and compliance. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in Rockwell Medical's SEC filings), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include but are not limited to those risks more fully discussed in the "Risk Factors" section of our Annual Report on Form 10-K for the year ended December 31, 2025, as such description may be amended or updated in any future reports we file with the SEC. Rockwell Medical expressly disclaims any obligation to update our forward-looking statements, except as may be required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260722472051/en/

Heather Hunter
(248) 432-1362
IR@rockwellmed.com

Source: Rockwell Medical