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...
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Blog
Stay informed and ahead of the curve with Trinity M Consulting's expert perspectives and industry knowledge.
- Sep 24
- 4 min
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
- 2 min
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
- 3 min
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
- 3 min
Preparing for FDA Pre-Submission and 513(g) Requests
Preparing for FDA Pre-Submission and 513(g) Requests.
- Sep 6
- 3 min
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
- 3 min
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
- 4 min
Orphan Drug Designation (ODD): An overview and Helpful Steps to Application
Orphan Drug Designation (ODD): An overview and Helpful Steps to Application.
- Jul 29
- 2 min
Explore OneGlobal Trinity M Consulting Quality Services
Explore OneGlobal Trinity M Consulting Quality Services.
- Jul 27
- 3 min
Navigating the Transition to QMSR with OneGlobal Trinity M Consulting
Navigating the Transition to QMSR with OneGlobal Trinity M Consulting.
- Jul 8
- 2 min
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
- 3 min
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
- 3 min
Understanding the Differences Between 510(k) and PMA
Understanding the Differences Between 510(k) and PMA.
- Jul 1
- 3 min
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
- 3 min
Best Practices for Obtaining FDA Approval for Medical Devices
Best Practices for Obtaining FDA Approval for Medical Devices.
- Jun 10
- 3 min
Best Practices for Creating and Maintaining a Quality Management System
Best Practices for Creating and Maintaining a Quality Management System.
- May 31
- 3 min
Establishing a Medical Device Facility: Helpful considerations.
Establishing a Medical Device Facility: Helpful considerations.
- May 29
- 3 min
Navigating Recent Regulatory Changes: Impact on Manufacturers
Navigating Recent Regulatory Changes: Impact on Manufacturers.
- May 23
- 3 min
Successfully Submitting a New NDA Under eCTD Version 4.0
Successfully Submitting a New NDA Under eCTD Version 4.0.
- May 23
- 3 min
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.
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