Arazy Group Consultants

Arazy Group Consultants is an international consultancy spanning several continents, assisting medical and IVD device companies with regulatory compliance and affairs as they try to enter new markets. Founded in 1995, Arazy Group operates in over 125 countries around the world. Arazy Group has been serving early start-up, medium-sized, and top 100 multinational MedTech companies.

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September 8th, 2020 On August 14, 2020, Arazy Group received its fastest Traditional 510(k) clearance via the FDA’s new expedited 30-day Triage Quick route. This is an option that the Triage Quick program is offering any Traditional 510(k) submission that meets its criteria. The Traditional 510(k) submission, K202068, which was sent for Triage Quick...
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