Hooman NoorchashmThe Coming Sea Change at Trump’s FDA: Towards an Era of Safety and Public Transparency for Medical…It has been over a decade since my late-wife, Dr. Amy Josephine Reed, was harmed and killed by a poorly regulated medical device, known as…4d ago
Elexes Medical ConsultingDe Novo — A Propeller for Innovation!While regulatory bodies across the world consistently want to make sure that every device entering the market is safe and effective, never…Feb 7, 2019
InI3CGLOBAL BlogsbySEO Agency510k When to Submit: Comprehensive GuideIf you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how…Oct 23Oct 23
InI3CGLOBAL BlogsbySEO AgencyHow Long Does It Take to Get 510k ApprovalManufacturers of medical devices that wish to enter the U.S. market must follow the FDA’s 510k procedure. “How long does it take to get…Oct 15Oct 15
InI3CGLOBAL BlogsbySEO AgencyFDA 510k Clearance vs Approval ServicesIt’s not always obvious if a given product needs FDA 510k Clearance and approval, even though the US medical device market entry process…Sep 18Sep 18
Hooman NoorchashmThe Coming Sea Change at Trump’s FDA: Towards an Era of Safety and Public Transparency for Medical…It has been over a decade since my late-wife, Dr. Amy Josephine Reed, was harmed and killed by a poorly regulated medical device, known as…4d ago
Elexes Medical ConsultingDe Novo — A Propeller for Innovation!While regulatory bodies across the world consistently want to make sure that every device entering the market is safe and effective, never…Feb 7, 2019
InI3CGLOBAL BlogsbySEO Agency510k When to Submit: Comprehensive GuideIf you are a medical device manufacturer considering entering the U.S. market, and you want to market your product, you must understand how…Oct 23
InI3CGLOBAL BlogsbySEO AgencyHow Long Does It Take to Get 510k ApprovalManufacturers of medical devices that wish to enter the U.S. market must follow the FDA’s 510k procedure. “How long does it take to get…Oct 15
InI3CGLOBAL BlogsbySEO AgencyFDA 510k Clearance vs Approval ServicesIt’s not always obvious if a given product needs FDA 510k Clearance and approval, even though the US medical device market entry process…Sep 18
InI3CGLOBAL BlogsbySEO AgencyA Brief Overview of FDA’s 513(g) Submission servicesAs far as regulations are concerned, there is no other sector that is as regulated as the medical devices sector in the world. New to these…Sep 15
InI3CGLOBAL BlogsbySEO Agency510(k) Clearance vs Approval Services Key DifferencesIt’s not always obvious if a given product needs FDA approval or a 510(k) clearance, even though the US medical device market entry process…Sep 9
InI3CGLOBAL BlogsbySEO AgencySpecial 510k Guidance Services By I3CGlobalParticularly with regard to medical device regulation, it is essential that manufacturers navigate the approval processes with precision…Jul 16
