…news and updates on key topics CDRH Guidance documents – Includes all guidance documents related to FDA regulated medical devices and radiation emitting products 510(k) submission process – Explanation of…
…news and updates on key topics CDRH Guidance documents – Includes all guidance documents related to FDA regulated medical devices and radiation emitting products 510(k) submission process – Explanation of…
…elbow grease and a reasonable monitoring program. The good news is the ISO standards have already defined what the action and alert limits should be for a cleanroom premised on…
…elbow grease and a reasonable monitoring program. The good news is the ISO standards have already defined what the action and alert limits should be for a cleanroom premised on…
…good news is a hacker would need to be reasonably close to a BLE device in order to hack it. The bad news is addressing some of these security vulnerabilities…
…good news is a hacker would need to be reasonably close to a BLE device in order to hack it. The bad news is addressing some of these security vulnerabilities…
…will probably be a significant number. The good news is that the results of these audits never have to be shared with our dear friends from the Agency. In accordance…
…will probably be a significant number. The good news is that the results of these audits never have to be shared with our dear friends from the Agency. In accordance…
…Form 483 Observation is an art form. For starters, regardless of what the investigator states verbally, establishments have 15 days to respond to the initial observations. The good news is…
…Form 483 Observation is an art form. For starters, regardless of what the investigator states verbally, establishments have 15 days to respond to the initial observations. The good news is…
…a medical device is alarming to everyone involved, the good news is that when a risk is discovered, it can often be fixed with a software patch or update. In…
…a medical device is alarming to everyone involved, the good news is that when a risk is discovered, it can often be fixed with a software patch or update. In…
…it will not own or operate a clinical lab within until 2019. According to a Theranos news release, the company left the clinical lab and retail business in 2016 and…
…it will not own or operate a clinical lab within until 2019. According to a Theranos news release, the company left the clinical lab and retail business in 2016 and…
…to fail to initiate therapy, which has been associated with a patient death. According to a news release on the Maquet Getinge Group website (Datascope is part of Maquet Getinge),…
…to fail to initiate therapy, which has been associated with a patient death. According to a news release on the Maquet Getinge Group website (Datascope is part of Maquet Getinge),…
…home €2000, second place wins €1000 and third place takes home €500. To submit a medical mobile solution for the competition, go to http://www.medica.de/mac2. View last year’s winners: https://medtechintelligence.com/news_article/medicas-medical-mobile-app-competition-winners-announced/ …
…home €2000, second place wins €1000 and third place takes home €500. To submit a medical mobile solution for the competition, go to http://www.medica.de/mac2. View last year’s winners: https://medtechintelligence.com/news_article/medicas-medical-mobile-app-competition-winners-announced/ …
…FBI alerts by emailing Cywatch@ic.fbi.gov alerts. This resource will keep companies updated on breaking news and other FBI updates in cybersecurity. The agency also encourages device companies to have a…
…FBI alerts by emailing Cywatch@ic.fbi.gov alerts. This resource will keep companies updated on breaking news and other FBI updates in cybersecurity. The agency also encourages device companies to have a…
