Lately, I’ve been reflecting on how often companies underestimate the complexity of global regulator...
Mastering Regulatory Compliance: Insights from Singapore’s Good Submission Practice Workshop 2024 Si...
Exploring the complex landscape of EU regulations for medical devices and in-vitro diagnostic device...
In August 2024, the FDA released significant guidance impacting the Medical Device De Novo submissio...
Edit Zur, a seasoned Regulatory Affairs Specialist, has been a driving force at Arazy Group for over...
Malaysia's Medical Device Authority (MDA) has just released an important regulatory update that coul...
Health Canada Draft Guidance: Interpretation of Significant Change of a Medical Device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 that...
Brazil's Draft Resolution 1200, dated September 1st, 2023, outlining a streamlined process for evalu...