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 Uncategorized June 30, 2022 Information required for MHRA Registration Registration The following are the information requested by MHRA Registration of Medical Devices. Manufact... 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 Medical Device March 30, 2022 What is Literature Search All the scientific articles are gathered together as a primary part of the clinical evaluation. MEDD... 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