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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