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 FDA 513g Guidance Medical Device manufacturers often file a FDA 513g request to establish if the requirements apply to... 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 Uncategorized June 30, 2022 MHRA Medical Device Registration The following is the information requested by the MHRA for medical device registration: Manufacturer... Read More
I3CGLOBAL FDA, Medical Device, Resources June 11, 2022 How To Register A Product With The FDA FDA Registration for New Drug is mandatory if you want to sell OTC and over the counter drug product... 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 FDA 510k * In general, clinical studies will not be needed for most surgical suture devices, FDA may recommen... Read More