Medical Device Claims

Medical Devices | FDA - U.S. Food and Drug Administration

https://www.fda.gov/Medical-Devices

Cybersecurity, mobile medical apps, wireless medical devices, AI/ML in Software as a Medical Device (SaMD), Interoperability Science and Research CDRH research programs, epidemiology,...

How to best set claims for a medical device

https://www.avanti-europe.ch/how-to-best-set-claims-for-a-medical-device/

Claims are the focus point for medical device safety and performance How to best set claims for a medical device The claim Claims don’t fall from the sky! Instead, claims are developed and well thought …

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

Medical Device Defect Lawsuits | AllLaw

https://www.alllaw.com/personal-injury/when-youre-injured-by-a-defective-medical-device.html

A medical device isn't usually classified as having a defective design. A manufacturing defect occurs when a product is manufactured in a way that deviates from the design, …

5 Must-Knows About Medical Device Claims | Maggio

https://www.mtlawms.com/blog/2018/september/5-must-knows-about-medical-device-claims/

Understand what is considered to be a “medical device” “Medical device” is the term used by …

Claims and their substantiation - LinkedIn

https://www.linkedin.com/pulse/claims-substantiation-jerome-randall-phd/?published=t

Whether you are a start-up or a well-established medical device manufacturer, Medidee will assist you in the planning and execution of your verification …

Types of Claims In Medical Device Patent …

https://arapackelaw.com/patents/medical-device/types-of-claims-in-medical-device-patent-applications/

Medical Device Patents: Combination or System Claims System claims are patent claims that combine various physical elements or parts to form an invention and no method is …

FDA Regulation of Medical Device …

https://www.corporatecomplianceinsights.com/fda-regulation-of-medical-device-advertising-and-promotion/

FDA determines the intended use of a medical device by looking at a wide body of evidence, such as: “labeling claims, advertising matter, or oral or written statements” or circumstances …

Requirements for "Claims Guide" for medical devices

https://elsmar.com/elsmarqualityforum/threads/requirements-for-claims-guide-for-medical-devices.79323/

For claims? Two columns. 1. The marketing / labeling claim. 2. Objective evidence. Thanks for your response. Yes, this is for US market. Similar to the DV …

MDR - Article 7 - Claims - Medical Device Regulation

https://www.medical-device-regulation.eu/2019/07/05/mdr-article-7-claims/

Claims In the labelling, instructions for use, making available, putting into service and advertising of devices, it shall be prohibited to use text, names, trademarks, …