Medical Device Raw Materials

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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.

Medical Device Material Safety Summaries | FDA

https://www.fda.gov/medical-devices/science-and-research-medical-devices/medical-device-material-safety-summaries

Cobalt Chromium (CoCr) Cyanoacrylates Hyaluronic Acid (HA) Magnesium Nitinol PEG (polyethylene glycol), used broadly and as a coating for …

Medical Device Classification and Plastic Material Selection

https://www.solvay.com/en/chemical-categories/specialty-polymers/healthcare/medical-device-classification-and-plastic

These documents may include formulation information, sterilization compatibility, recommended processing methods, ISO 10993 test results and other data that can …

Selecting materials for medical devices

https://www.team-consulting.com/insights/selecting-materials-for-medical-devices/

When developing a medical device, selecting the right material for each part is a fundamental step, one which demands …

Raw Materials for Medical Device - CIRS Group

https://www.cirs-group.com/en/md/raw-materials-for-medical-device

Raw Materials for Medical Device. Sep 08, 2021. Regulation Registration. Many chemical companies produce polymers, additives, intermediates, co …

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

Raw materials: “Changes in raw material suppliers or raw material specifications could introduce different types or quantities of residual chemicals and could …

Materials for Medical Manufacturing

https://www.sme.org/technologies/articles/2011/materials-medical-manufacturing/

“With implantable orthopedic medical devices, typical materials might be stainless, titanium, or PEEK. For an implantable dental device, like an abutment, titanium, stainless, zirconium, or …

Medical Device Raw Material Traceability Requirements

https://elsmar.com/elsmarqualityforum/threads/medical-device-raw-material-traceability-requirements.64666/

Preparing a document for Raw Material of Medical Device: EU Medical Device Regulations: 1: Nov 3, 2021: M: Are Medical device Raw material suppliers required to …

Purchasing Controls - Food and Drug Administration

https://www.fda.gov/files/drugs/published/Purchasing-Controls---Devices.pdf

Definition: Component Componentmeans any raw material, substance, piece, part, software, firmware, labeling, or assemblywhich is intended to be included as part of the …

MDR and Materials: How Medical Device …

https://www.ansys.com/blog/mdr-how-medical-device-manufacturers

In short, medical device manufacturers are facing some of the most disruptive regulations in recent memory. They are turning to technology for help. One of the biggest changes from MDD to …

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