Raw Material Specifications Medical Devices

Safety of Metals and Other Materials Used in Medical …

https://www.fda.gov/medical-devices/products-and-medical-procedures/safety-metals-and-other-materials-used-medical-devices

Numerous types of materials, including metals, polymers and ceramics, are commonly used in medical devices, and these materials can be in contact with parts of the body for extended periods of time.

Component and Device Documentation Examples

https://www.fda.gov/medical-devices/biocompatibility-assessment-resource-center/component-and-device-documentation-examples-test-articles-or-previously-marketed-devices

CGMP controlled Raw Materials – Regulations and Best …

https://www.complianceonline.com/cgmp-controlled-raw-materials-regulations-and-best-practices-16760-prdad

Raw Materials are quarantined after initial receipt and verification process Store in a Controlled Conditions (Temperature and Humidity Control) Quarantine, …

Structure of Technical Documentation (Medical Devices)

https://www.mdc-ce.de/fileadmin/user_upload/Downloads/mdc-Dokumente/Formulare_Recommend/2379_e_Structure_of_Technical_Documentation_Medical_Devices.pdf

Specifications of raw materials/components/subassemblies, e.g. technical specifications, features, dimensions and performance attributes, of the device and any …