Custom Medical Device

Custom Device Exemption | FDA

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/custom-device-exemption

Center for Devices and Radiological Health The Food and Drug Administration (FDA) has developed this document to provide guidance to industry and FDA staff about …

Home - CMD - Custom Medical Devices

https://cmdinc.org/

Home - CMD - Custom Medical Devices Primarily used in Interventional Radiology, Angiography, Cardiology, and Vascular Surgery High Purity Medical Carbon Dioxide …

Custom Medical Device Design and Manufacturing

https://www.controltek.com/custom-medical-device-design-and-manufacturing

MDR requirements for custom-made medical devices

https://mdrregulator.com/news/custom-made-medical-devices-mdr

The manufacturer of custom-made devices is obliged to implement the procedure for custom-made devices in accordance with Annex XIII of the Regulation …