Mastering Regulatory Compliance: Insights from Singapore’s Good Submission Practice Workshop 2024 Si...
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How an EU Authorized Rep Can Boost Your MedTech Success
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...
On February 5, 2024, the Saudi Food & Drug Authority (SFDA) marked a significant milestone with the ...
In Brazil, a significant regulatory development in the realm of healthcare emerged with the issuance...
In a significant move to enhance patient care and transparency within the medical devices sector, th...