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Stay informed and ahead of the curve with Trinity M Consulting's expert perspectives and industry knowledge.
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
Completing Post-Marketing Surveillance Reports for Medical Devices
Completing Post-Marketing Reports for Medical Devices
May 14, 20243 min read
Global Regulatory Requirements for Medical Devices
Global Regulatory Requirements for Medical Devices.
May 13, 20242 min read
Navigating the MDSAP Audit: A Guide to Readiness
Navigating the MDSAP Audit: A Guide to Readiness.
Apr 29, 20243 min read
Navigating FDA QMSR Changes: A Guide to Compliance
Navigating FDA QMSR Changes: A Guide to Compliance
Apr 23, 20242 min read
The Essentials of Electronic Common Technical Document (eCTD) Submissions: A Guide for Regulatory Affairs Professionals
The Essentials of Electronic Common Technical Document (eCTD) Submissions: A Guide for Regulatory Affairs Professionals
Apr 16, 20243 min read
Pioneering Excellence in the Medical Device, Pharmaceutical, and Biotechnology Industry.
Pioneering Excellence in the Medical Device, Pharmaceutical, and Biotechnology Industry.
Apr 9, 20243 min read
OneGlobal Trinity M Consulting: Comprehensive Services and Solutions Tailored for the Biotech, Pharmaceutical, and Medical Device Industries
OneGlobal Trinity M Consulting Comprehensive Services and Solutions Tailored for the Biotech, Pharmaceutical, and Medical Device Industries.
Apr 7, 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 Evolving Global Regulatory Landscape for Medical Devices: Insights and Implications
Introduction The regulation of medical devices plays a pivotal role in ensuring that products available in the market are safe and...
Apr 2, 20242 min read
How to Register a Medical Device in Latin America: A Comprehensive Guide
Introduction: Latin America represents a promising market for medical devices, characterized by a diverse regulatory landscape. Entering...
Apr 2, 20243 min read
Navigating Complex Regulatory Submissions with OneGlobal Trinity M Consulting: Key Reminders for Launching Medical Devices and New Drugs
In the ever-evolving landscape of healthcare, regulatory compliance stands as a cornerstone of ensuring patient safety and product...
Mar 13, 20243 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
Regulatory Affairs Professionals Society (RAPS) Proud Member
We are committed to keeping up to date with Regulatory Affairs continuing education and keeping up to date with industry standards and...
Feb 13, 20241 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
Bringing Innovations to Market: How Trinity M Consulting Supports the Medical Device, Pharmaceutical, and Biotechnology Industry
Bringing Innovations to Market: How Trinity M Consulting Supports the Medical Device, Pharmaceutical, and Biotechnology Industry.
Feb 9, 20242 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
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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