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Stay informed and ahead of the curve with Trinity M Consulting's expert perspectives and industry knowledge.
5 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
5 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.
6 days ago3 min read
The Impact of AI in Medical Devices
Artificial Intelligence (AI) is revolutionizing the medical device industry.
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)
Nov 3, 20244 min read
Best Practices for Updating Your Medical Device File
Best Practices for Updating Your Medical Device File...
Oct 10, 20244 min read
Conducting an Effective Regulatory Strategy
Conducting an Effective Regulatory Strategy...
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.
Aug 13, 20243 min read
The Importance of Medical Writing in Regulatory Submissions
The Importance of Medical Writing in Regulatory Submissions.
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 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 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 26, 20243 min read
Navigating the Regulatory Requirements for Obtaining CE Marking for Medical Devices
Navigating the Regulatory Requirements for Obtaining CE Marking for Medical Devices
Jun 24, 20242 min read
Medical Device Submission to Health Canada: Helpful Reminders
Medical Device Submission to Health Canada: Helpful Reminders
May 31, 20243 min read
Establishing a Medical Device Facility: Helpful considerations.
Establishing a Medical Device Facility: Helpful considerations.
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