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Recently-Approved Devices | FDA
- https://www.fda.gov/medical-devices/device-approvals-denials-and-clearances/recently-approved-devices
- Humanitarian Device Exemptions (HDE): Listing of devices that have been approved to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States per...
Recent Final Medical Device Guidance Documents | FDA
- https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents
- Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in …
Medical devices - World Health Organization
- https://www.who.int/health-topics/medical-devices
- Today, there are an estimated 2 million different kinds of medical devices on the world market, categorized into more than 7000 generic devices groups. A medical …
Medical Devices | FDA - U.S. Food and Drug Administration
- https://www.fda.gov/Medical-Devices
- Approvals and clearances, information on medical devices by type Digital Health Center of Excellence Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in …
The 18 most innovative medical devices of …
- https://www.medicaldesignandoutsourcing.com/the-18-most-innovative-medical-devices-of-2021/
- The Galien Foundation today announced the nominees for most innovative medical devices for its 15th annual Prix Galien USA Awards. The foundation …
New Medical Devices: Invention, Development, and Use
- https://pubmed.ncbi.nlm.nih.gov/25032312/
- Issues that shape the invention of new medical devices and affect their introduction and use are explored in this volume. The authors examine the role of federal support, the …
The 18 most innovative medical devices of …
- https://www.medicaldesignandoutsourcing.com/the-18-most-innovative-medical-devices-of-2020/
- The Galien Foundation recently announced nominees for most innovative medical devices for its 14th Annual Prix Galien USA Awards. The foundation …
REACH FAQs for Medical Device …
- https://www.mddionline.com/regulatory-quality/reach-faqs-medical-device-professionals
- REACH FAQs for Medical Device Professionals. The EU regulation may have been around for more than a decade, but there is still a lot for medtech to …
Medical Devices - Sector - Public Health
- https://health.ec.europa.eu/medical-devices-sector_en
- The following medical devices Directives were repealed and replaced by Regulation (EU) 2017/746 and Regulation (EU) 2017/745 respectively... New Regulations …
Factsheet: medical devices overview
- https://www.gov.uk/government/publications/medicines-and-medical-devices-bill-overarching-documents/factsheet-medical-devices-overview
- A medical device is any apparatus, appliance, software, material or other article, whether used alone or in combination, intended by the manufacturer to be used by …
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