Designing Antimicrobial Medical Devices

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Frontiers | The Mechanisms and the Applications of …

https://www.frontiersin.org/articles/10.3389/fbioe.2020.00910/full

Various medical devices, such as intravascular catheters, heart valves, orthopedic implants, dental implants, and contact lenses are often used clinically to treat diseases (Francolini et al., 2015). However, there are often a large number of pathogenic microorganisms such as bacteria and fungi in the … See more

Antimicrobials | Nature Biotechnology

https://www.nature.com/articles/s41587-020-0488-1

Apr 7, 2020

Development of Antimicrobial Drugs and Antimicrobial …

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/coordinated-development-antimicrobial-drugs-and-antimicrobial-susceptibility-test-devices

This guidance is intended to assist drug sponsors and device manufacturers who are planning to develop new antimicrobial drugs and antimicrobial susceptibility …

The benefits and growth of antimicrobial medical devices

https://www.med-technews.com/medtech-insights/medtech-materials-and-assembly-insights/the-benefits-and-growth-of-antimicrobial-medical-devices/

Antimicrobial technology might be used on an entire item, or just on key touchpoints – such as side guards, buttons and levers on a patient stretcher. …

5 Antimicrobial-Related Trends In Medical Device Design

https://www.meddeviceonline.com/doc/antimicrobial-related-trends-in-medical-device-design-0001

While many manufacturers have found ways to incorporate antimicrobials into the surfaces of already-designed medical devices, which adds another layer of …

FDA-Recognized Antimicrobial Susceptibility Test …

https://www.fda.gov/drugs/development-resources/fda-recognized-antimicrobial-susceptibility-test-interpretive-criteria

Questions regarding the clearance, classification, or approval of antimicrobial susceptibility testing devices should be directed to the Division of Industry and Consumer …

Step 3: Pathway to Approval | FDA

https://www.fda.gov/patients/device-development-process/step-3-pathway-approval

Federal Food, Drug, and Cosmetic Act, section 513, established the risk-based device classification system for medical devices. Each device is assigned to one of three …

Medical Device Design: The Essential, Step …

https://www.kolabtree.com/blog/medical-device-design-the-essential-step-by-step-guide/

Medical device standards such as the International Electrotechnical Commission (IEC) or the International Organization for Standardization (ISO) …

Medical Device Design and Development: A …

https://www.einfochips.com/blog/medical-device-design-guide-for-medtech/

Step 1 (User Needs) Requirements are defined considering the market need and the device is designed to address that need. After series of evolution, …

Parker Hannifin | Antimicrobial Polymers for Medical …

https://www.parker.com/content/dam/Parker-com/Literature/Composite-Sealing-Systems-Division/Antimicrobial-Polymers-for-Medical-Devices-Technical-Bulletin.pdf

medical device design and manufacturing support from concept to production. From material formulation and processing, to full medical device fabrication and assembly, to …

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