FDA Final Rule Amending Quality Management System Regulation
On January 31, 2024, the FDA issued a significant final rule amending the Quality Management System Regulation (QMSR), which aligns […]
Mastering the MDR Transition: Expert Insights and Guidance | QREG
The shift towards the Medical Device Regulation (MDR) signifies a major transformation within the medical device sector in the European
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