Understanding UDI Compliance: A Details Guide for Medical Device Manufacturers
Welcome to our guide on navigating Unique Device Identification (UDI) compliance in the medical device industry. As the healthcare sector […]
Own Brand Labelling for Medical Devices | Optimise Compliance & Branding | QREG
Welcome to our latest blog post where we will be looking into Own Brand Labelling (OBL) in the medical device
CE Marking Process: Ensuring Medical Device
The CE marking process is a pivotal step for manufacturers looking to distribute their: This mark signifies compliance with the
FDA Update: Final Rule Amending the Quality System Regulation
The FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS)
MHRA Update: Roadmap towards the future regulatory framework for medical devices
The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its regulatory roadmap for the development of new and robust
Update: Australian Clinical Evidence Guidelines for Medical Devices
In November 2023 Australia’s regulatory board, Therapeutic Goods Administration (TGA) released a revision of the Clinical Evidence Guideline Version 3.2.
Revolutionising Medical Device Industry: The Impact of Digital Transformation on Quality Assurance and Regulatory Compliance
In the dynamic and highly regulated medical device industry, digital transformation is not just a buzzword but a fundamental shift
Own Brand Labelling- The Ins and Outs
Own Brand Labelling (OBL) in the medical device industry was a term used to define companies that market and sell
India postpones the implementation of licensing requirements for higher-risk medical devices.
In 2020, India outlined plans to revamp the regulatory framework for medical devices adopting a phased approach. While manufacturers of
Navigating Compliance: Understanding MDR Medical Device Technical Documentation
The European Union’s Medical Device Regulation (MDR) stands as a comprehensive framework ensuring the safety and efficacy of medical devices