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Stay informed and ahead of the curve with Trinity M Consulting's expert perspectives and industry knowledge.
6 days ago3 min read
Manufacturing Inspections for Medical Devices in the USA: FDA Requirements and Best Practices
Manufacturing Inspections for Medical Devices in the USA: FDA Requirements and Best Practices
6 days ago3 min read
Best Practices for Maintaining a Quality Management System
In the highly regulated medical device industry, maintaining a Quality Management System (QMS) that complies with ISO 13485:2016 is crucial.
Feb 102 min read
The FDA’s Quality Management System Regulation (QMSR) Takes Effect February 2, 2026: What You Need to Know
The FDA’s Quality Management System Regulation (QMSR) Takes Effect February 2, 2026: What You Need to Know
Nov 11, 20245 min read
Understanding IVDR Technical Documentation Requirements for In Vitro Diagnostic Devices (IVDs)
Understanding IVDR Technical Documentation Requirements for In Vitro Diagnostic Devices (IVDs)
Sep 30, 20244 min read
Tips for Creating a Regulatory Pathway for a Medical Device to be Sold in the USA
Navigating the regulatory landscape for bringing a medical device to market in the US can be challenging but essential to product safety...
Sep 24, 20244 min read
Understanding Regulatory, Quality, and Post-Market Requirements for OTC Drug Submissions: U.S. and India
In this blog, we will outline the key requirements for OTC drug submissions in both the U.S. (FDA) and India.
Sep 19, 20242 min read
Navigating FDA Requirements for Combination Products and Post-Market Reporting
Combination products, which integrate medical devices with drugs or biologics, are subject to stringent FDA regulations.
Sep 12, 20243 min read
Navigating the Complex World of Regulatory Approval: A Step-By-Step Guide for Success
Navigating the Complex World of Regulatory Approval: A Step-By-Step Guide for Success
Sep 12, 20243 min read
Preparing for FDA Pre-Submission and 513(g) Requests
Preparing for FDA Pre-Submission and 513(g) Requests.
Sep 6, 20243 min read
5 Tips for Quality Checks in Maintaining an Effective Quality Management System (QMS)
5 Tips for Quality Checks in Maintaining an Effective Quality Management System (QMS)
Sep 3, 20243 min read
Navigating Market Entry in the USA: Essential Regulatory Strategies and How OneGlobal Trinity M Consulting Can Help
Navigating Market Entry in the USA: Essential Regulatory Strategies and How OneGlobal Trinity M Consulting Can Help
Aug 2, 20244 min read
Orphan Drug Designation (ODD): An overview and Helpful Steps to Application
Orphan Drug Designation (ODD): An overview and Helpful Steps to Application.
Jul 29, 20242 min read
Explore OneGlobal Trinity M Consulting Quality Services
Explore OneGlobal Trinity M Consulting Quality Services.
Jul 27, 20243 min read
Navigating the Transition to QMSR with OneGlobal Trinity M Consulting
Navigating the Transition to QMSR with OneGlobal Trinity M Consulting.
Jul 8, 20242 min read
The FDA’s Final Rule on Laboratory Developed Tests (LDTs): What it Means for Clinical Laboratories
The FDA’s Final Rule on Laboratory Developed Tests (LDTs): What It Means for Clinical Laboratories
Jul 8, 20243 min read
Finding the Right Consulting Company: Your Path to Success with OneGlobal Trinity M Consulting
Finding the Right Consulting Company: Your Path to Success with OneGlobal Trinity M Consulting.
Jul 3, 20243 min read
Understanding the Differences Between 510(k) and PMA
Understanding the Differences Between 510(k) and PMA.
Jul 1, 20243 min read
How to Successfully Obtain Regulatory Approval for an OTC Product: Navigating FDA Requirements
How to Successfully Obtain Regulatory Approval for an OTC Product: Navigating FDA Requirements
Jun 12, 20243 min read
Best Practices for Obtaining FDA Approval for Medical Devices
Best Practices for Obtaining FDA Approval for Medical Devices.
Jun 10, 20243 min read
Best Practices for Creating and Maintaining a Quality Management System
Best Practices for Creating and Maintaining a Quality Management System.
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