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Stay informed and ahead of the curve with Trinity M Consulting's expert perspectives and industry knowledge.
Understanding the Differences Between 510(k) and PMA
Understanding the Differences Between 510(k) and PMA.
Jul 2, 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
Jul 1, 20243 min read
Best Practices for Obtaining FDA Approval for Medical Devices
Best Practices for Obtaining FDA Approval for Medical Devices.
Jun 12, 20243 min read
Best Practices for Creating and Maintaining a Quality Management System
Best Practices for Creating and Maintaining a Quality Management System.
Jun 10, 20243 min read
Establishing a Medical Device Facility: Helpful considerations.
Establishing a Medical Device Facility: Helpful considerations.
May 31, 20243 min read
Navigating Recent Regulatory Changes: Impact on Manufacturers
Navigating Recent Regulatory Changes: Impact on Manufacturers.
May 29, 20243 min read
Successfully Submitting a New NDA Under eCTD Version 4.0
Successfully Submitting a New NDA Under eCTD Version 4.0.
May 23, 20243 min read
How to Prepare for an Advisory Meeting with the FDA: A Comprehensive Guide
How to Prepare for an Advisory Meeting with the FDA: A Comprehensive Guide.
May 23, 20243 min read
Navigating the Latest Updates to the FDA's Quality Management System Regulation (QMSR)
Navigating the Latest Updates to the FDA's Quality Management System Regulation (QMSR)
May 21, 20244 min read
Preparing for an FDA Q-Sub Meeting
Preparing for an FDA Q-Sub Meeting.
May 9, 20242 min read
Navigating FDA QMSR Changes: A Guide to Compliance
Navigating FDA QMSR Changes: A Guide to Compliance
Apr 23, 20242 min read
The Path to Launching a Medical Device in the USA: A Guide by OneGlobal Trinity M Consulting
The Path to Launching a Medical Device in the USA: A Guide by OneGlobal Trinity M Consulting.
Apr 5, 20243 min read
Navigating the Path to Regulatory Approval: Preparing an eCTD Submission for a New Drug in the US
Introduction: The process of bringing a new drug to market involves numerous steps, with one critical milestone being the submission of a...
Feb 28, 20242 min read
Getting Ready for an FDA Medical Device Inspection: Helpful Reminders and Trinity M Consulting's Support
Getting Ready for an FDA Medical Device Inspection: Helpful Reminders and Trinity M Consulting's Support
Feb 19, 20242 min read
Importance of a well written FDA submission: Helpful Reminders
Introduction: A thorough FDA regulatory submission is paramount for ensuring the safety, efficacy, and market success of medical devices....
Feb 15, 20242 min read
Understanding the FDA's Final Rule Amending Quality Management System Regulation
The Food and Drug Administration (FDA) plays a crucial role in ensuring the safety and efficacy of medical devices in the United States....
Feb 15, 20243 min read
Navigating the FDA Submission Process for Medical Device Products: Six Helpful Reminders
Introduction: Submitting a medical device product to the U.S. Food and Drug Administration (FDA) can be a complex and daunting task, but...
Feb 9, 20243 min read
Elevating Clinical Consulting: Trinity M Consulting as Your Strategic Partner
In the ever-evolving landscape of healthcare, the clinical development and regulatory approval processes are crucial milestones for...
Jan 24, 20244 min read
Unlocking Success: The Crucial Role of Soft Skills in Regulatory Affairs for Medical Devices
In the fast-paced and highly regulated landscape of the medical device industry, the importance of technical expertise in regulatory...
Jan 22, 20245 min read
Navigating the FDA Warning Letter Journey: A Comprehensive Guide and Trinity M Consulting’s Expertise
Receiving a Warning Letter from the U.S. Food and Drug Administration (FDA) can be a daunting experience for any medical device...
Jan 16, 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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