The world of medical technology is transforming, not just in innovation but also in how these...
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Mastering Regulatory Compliance: Insights from Singapore’s Good Submission Practice Workshop 2024...
Exploring the complex landscape of EU regulations for medical devices and in-vitro diagnostic...
In August 2024, the FDA released significant guidance impacting the Medical Device De Novo...
Edit Zur, a seasoned Regulatory Affairs Specialist, has been a driving force at Arazy Group for...
Malaysia's Medical Device Authority (MDA) has just released an important regulatory update that...
Health Canada Draft Guidance: Interpretation of Significant Change of a Medical Device
On March 18, 2024, the Center for Medical Device Evaluation (CMDE) released an important Notice...
Brazil's Draft Resolution 1200, dated September 1st, 2023, outlining a streamlined process for...
In a move aimed at bolstering the quality management of medical device operations across China, the...
On November 20, 2023, a significant development unfolded in the realm of medical device regulation...