Opinion On Comparing One Medical Device To Another

Device Evaluations - ECRI

https://www.ecri.org/solutions/evaluation-and-comparison

Understand and compare medical devices based on laboratory testing, ratings, and specification recommendations. Medical product inventories have continually grown in both size and sophistication. For clinical engineering, biomedical technology, and risk …

Patient Access to Medical Devices — A …

https://www.nejm.org/doi/full/10.1056/NEJMp1204170

Patient Access to Medical Devices — A Comparison of U.S. and European Review Processes …

Are Medical AI Devices Evaluated Appropriately?

https://hai.stanford.edu/news/are-medical-ai-devices-evaluated-appropriately

A new study finds limitations in the FDA’s approval process. In just the last two years, artificial intelligence has become embedded in scores of medical devices …

FDA Clearance vs. FDA Approval Process for Medical …

https://www.goodrx.com/healthcare-access/medication-education/fda-approval-vs-fda-clearance

Opinion | Can Your Hip Replacement Kill You? - The New York …

https://www.nytimes.com/2018/01/13/opinion/sunday/can-your-hip-replacement-kill-you.html

About 32 million Americans — or about one in 10 — have at least one medical device implanted, from artificial joints to cardiac stents, surgical mesh, …

Medical Devices: Substantial Equivalence vs.

https://www.celegence.com/medical-devices-substantial-equivalence-vs-demonstration-equivalence/

For many companies, it is a challenge just to find adequate regulatory resources to compile this exhaustive list of medical device characteristics for both the device under …

Opinion On Comparing One Medical Device To Another

https://dayofdifference.org.au/o-medical/opinion-on-comparing-one-medical-device-to-another.html

One frequently heard misconception centres on the difference in availability of clinical evidence for pharmaceuticals and medical devices, including (inaccurate) claims that no …

Importing Medical Devices | FDA

https://www.fda.gov/industry/importing-fda-regulated-products/importing-medical-devices

Depending on the Class of the medical device you are importing, the submission types will differ. Step 1: Search Searching on the word toothbrush will provide …

How to Determine if Your Product is a Medical Device | FDA

https://www.fda.gov/medical-devices/classify-your-medical-device/how-determine-if-your-product-medical-device

Finding an existing classification that describes your product's intended use or design is a good indicator that it might be a medical device. Three methods to …

Which Medical Device

https://www.whichmedicaldevice.com/

Which Medical Device is a community of clinicians sharing knowledge and experience of the devices and procedures we use on a daily basis. We ask that our members register …