In January 2024, the FDA issued a landmark Quality Management System Regulation (QMSR) final rule that overhauls 21 CFR Part 820 to incorporate ISO 13485:2016
Introduction Medical device companies today face a complex web of regulations when marketing products globally. Unique Device Identification (UDI) systems have been adopted worldwide to
In digital health and precision oncology, trust is everything. Patients, clinicians, collaborators, and investors all want to know that sensitive data is handled with the
Navigating post-market compliance under MDR/IVDR has never been more complex. As regulatory demands rise, responsibility no longer rests solely with the manufacturer, it extends across
Where the European Medical Device Regulations (MDR 2017/745 & IVDR 2017/746) have significantly increased the regulatory burden for Legal Manufacturers and Authorised Representatives of medical
Under the EU Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, compliance responsibilities are distributed across various economic operators
Compliance with the Medical Device Regulation (MDR) and In-Vitro Medical Regulation (IVDR) is crucial in the complex and highly regulated medical device landscape of the
Today marks a milestone for the EU as the AI Act enters into force after three years of development. The EU leads as the first to establish a robust AI regulatory framework. With the countdown for implementation beginning, let’s explore the timelines ahead.
Today marks a milestone for the EU as the AI Act enters into force after three years of development. The EU leads as the first to establish a robust AI regulatory framework. With the countdown for implementation beginning, let’s explore the timelines ahead.
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