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Here are essential deadlines, new post-market surveillance rules, and compliance strategies for unin...

Accelerating Innovation: Saudi Arabia’s Fast Track Pathways for Innovative Medical Devices

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...

On March 18, 2024, the Center for Medical Device Evaluation (CMDE) released an important Notice that...

Exciting news from the EU as the "AI Act" receives final approval, ushering in comprehensive regulat...