I3CGLOBAL FDA 510k January 20, 2023 Performance Tests – Bench, Animal, Clinical Most 510(k) submissions will include some type of performance data. The extent of performance data w... Read More
I3CGLOBAL MDR CE MARKING October 4, 2022 Section 513(g) Section 513(g) of the FDA One of the difficulties that medical device manufacturers encounter is dec... Read More
I3CGLOBAL Biocompatibility Testing, FDA 510k, Resources June 30, 2022 FDA 510k Biocompatibility Assessment * In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen... Read More
I3CGLOBAL FDA, Medical Device, Resources June 11, 2022 Do You Need to Register and Label Your New Drug Product with the FDA? This Is How You Do It. ... Read More
I3CGLOBAL MDR CE MARKING, Resources April 11, 2022 How to CE Mark your Medical Devices and Avoid Problems! * In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen... Read More
I3CGLOBAL FDA 510k January 22, 2022 Surgical Sutures 510(k) * In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen... Read More
I3CGLOBAL MDR CE MARKING October 3, 2021 Person Responsible for Regulatory Compliance, (PRRC) The person responsible for regulatory compliance (PRRC) is not intended to take the place of a Europ... Read More