Lately, I’ve been reflecting on how often companies underestimate the complexity of global...

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Health Canada Draft Guidance: Interpretation of Significant Change of a Medical Device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...