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
Changes to UK Medical device regulations
Medical device regulation is of utmost importance in ensuring patient safety by establishing standards for the design, manufacturing, and performance