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Blog
Stay informed and ahead of the curve with Trinity M Consulting's expert perspectives and industry knowledge.
FDA Workforce Reductions & Regulatory Delays – What It Means for You
The recent FDA layoffs mark a significant shift in the Agency’s operational landscape.
Apr 34 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
Mar 173 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.
Mar 173 min read
The Impact of AI in Medical Devices
Artificial Intelligence (AI) is revolutionizing the medical device industry.
Mar 163 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
Feb 102 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 11, 20245 min read
OneGlobal Trinity M Consulting Uses ISO 9001 and ISO 27001 to Provide the Best Consulting Services for Medical Device, Biotech, and Pharma Companies
How OneGlobal Trinity M Consulting Uses ISO 9001 and ISO 27001 ...
Nov 3, 20244 min read
The Phases of Clinical Trials: Navigating the Path from Discovery to Approval
The Phases of Clinical Trials: Navigating the Path from Discovery to Approval
Nov 3, 20243 min read
Best Practices for Updating Your Medical Device File
Best Practices for Updating Your Medical Device File...
Nov 3, 20244 min read
Tips for Successful New Product Development in the Medical Device Industry
Tips for Successful New Product Development in the Medical Device Industry
Oct 29, 20244 min read
Conducting an Effective Regulatory Strategy
Conducting an Effective Regulatory Strategy...
Oct 10, 20244 min read
Effective Strategies for Conducting a Gap Assessment in Life Sciences
Effective Strategies for Conducting a Gap Assessment in Life Sciences...
Oct 5, 20244 min read
The Power of Project Management in Life Sciences and How OneGlobal Trinity M Consulting Can Help
The Power of Project Management in Life Sciences and How OneGlobal Trinity M Consulting Can Help...
Oct 5, 20243 min read
Navigating the Regulatory Pathway for Selling Class II Medical Devices in Canada
Navigating the Regulatory Pathway for Selling Class II Medical Devices in Canada...
Oct 1, 20243 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 30, 20244 min read
The Benefits of Partnering with a Consulting Firm: Why It’s the Smart Choice for Businesses
The Benefits of Partnering with a Consulting Firm: Why It’s the Smart Choice for Businesses
Sep 26, 20244 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 19, 20242 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 12, 20243 min read
Steps to Enter the European Market
Steps to Enter the European Market.
Sep 12, 20243 min read
Upcoming Events
- Feb 18 - Feb 20, 2025Feb 18 - Feb 20, 2025Dallas, 650 S Griffin St, Dallas, TX 75202, USAWe’re thrilled to announce that OneGlobal Trinity M Consulting will be attending the Medtrade Event at the Kay Bailey Hutchison Convention Center in Dallas, TX! 🗓️ Expo: February 19-20, 2025 🗓️ Conference: February 18-20, 2025 Join us as we connect with industry leaders, explore the latest innov
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