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Lets Meet @ WHX Miami Convention on June 12, 2025

At OneGlobal Trinity M Consulting, we partner with pharmaceutical, biotech, and medical device companies to navigate the unique regulatory, clinical, and strategic pathways required for successful orphan drug development and approval.

Partnering with OneGlobal Trinity M Consulting: Built on Values, Driven by Results

Empowering Life Sciences Innovation: Trinity M Consulting’s Expertise in Project Management, Regulatory, Quality, Clinical Trials, and Talent Solution

The recent FDA layoffs mark a significant shift in the Agency’s operational landscape.

Navigating the regulatory landscape of the U.S. Food and Drug Administration (FDA) is crucial for medical device manufacturers.

Manufacturing Inspections for Medical Devices in the USA: FDA Requirements and Best Practices

In the highly regulated medical device industry, maintaining a Quality Management System (QMS) that complies with ISO 13485:2016 is crucial.

Artificial Intelligence (AI) is revolutionizing the medical device industry.

The FDA’s Quality Management System Regulation (QMSR) Takes Effect February 2, 2026: What You Need to Know