Understanding IVDR Technical Documentation Requirements for In Vitro Diagnostic Devices (IVDs)
Understanding IVDR Technical Documentation Requirements for In Vitro Diagnostic Devices (IVDs)
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Blog
Stay informed and ahead of the curve with Trinity M Consulting's expert perspectives and industry knowledge.
Nov 34 min read
Best Practices for Updating Your Medical Device File
Best Practices for Updating Your Medical Device File...
Oct 104 min read
Conducting an Effective Regulatory Strategy
Conducting an Effective Regulatory Strategy...
Sep 304 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 244 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 192 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 123 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 123 min read
Preparing for FDA Pre-Submission and 513(g) Requests
Preparing for FDA Pre-Submission and 513(g) Requests.
Aug 133 min read
The Importance of Medical Writing in Regulatory Submissions
The Importance of Medical Writing in Regulatory Submissions.
Aug 24 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 82 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 23 min read
Understanding the Differences Between 510(k) and PMA
Understanding the Differences Between 510(k) and PMA.
Jul 13 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 263 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 242 min read
Medical Device Submission to Health Canada: Helpful Reminders
Medical Device Submission to Health Canada: Helpful Reminders
May 313 min read
Establishing a Medical Device Facility: Helpful considerations.
Establishing a Medical Device Facility: Helpful considerations.
May 293 min read
Navigating Recent Regulatory Changes: Impact on Manufacturers
Navigating Recent Regulatory Changes: Impact on Manufacturers.
May 233 min read
Successfully Submitting a New NDA Under eCTD Version 4.0
Successfully Submitting a New NDA Under eCTD Version 4.0.
May 233 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 214 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)
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