Author name: qreg.co.uk

The FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS)

The Medicines and Healthcare products Regulatory Agency (MHRA) has unveiled its regulatory roadmap for the development of new and robust

In November 2023 Australia’s regulatory board, Therapeutic Goods Administration (TGA) released a revision of the Clinical Evidence Guideline Version 3.2.

In the dynamic and highly regulated medical device industry, digital transformation is not just a buzzword but a fundamental shift

In 2020, India outlined plans to revamp the regulatory framework for medical devices adopting a phased approach. While manufacturers of

The European Union’s Medical Device Regulation (MDR) stands as a comprehensive framework ensuring the safety and efficacy of medical devices

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